An interventional study of Multisensory early oral administration of human milk in Infant, Premature, Diseases, sponsored by Loyola University. Recruiting at 2 sites in United States. Open to participants aged 23 Weeks to 32 Weeks. Per ClinicalTrials.gov, last updated 2026-01-20.
Sponsored by Loyola University · Not applicable, Interventional, and Prevention
The goal of this clinical trial is to learn if the multisensory early oral administration of human milk (M-MILK) intervention helps infants who are born younger than 32 weeks gestational age (very preterm infants). The main question that this clinical trial aims to answer is: Does M-MILK improve stress regulation, support optimal neurodevelopment, and promote competent oral feeding skills in very preterm infants?
Researchers will compare M-MILK to the standard of care to see if M-MILK helps very preterm infants. Specifically, researchers will compare the differences in:
88 studies on the registry are indexed under Infant, Premature, Diseases; 12 are open to participants now.
This study's planned enrollment of 125 is above the median of 63 across 57 interventional studies indexed under Infant, Premature, Diseases.
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Exclusion Criteria:
Infants in the M-MILK group will receive M-MILK intervention and standard of care. M-MILK is implemented starting on day 3 of life, during the day shift, after every hands-on care, during the beginning of a full gavage feeding, and up to 4 times a day. Infants receive M-MILK in small droplets via a 1-ml syringe. M-MILK will cease upon oral feeding initiation. Infants will receive either mother's own milk or donor's milk based on availability. Infants may receive up to 1 mL of milk each time based on their cues and responses. The 1 mL volume intake is included as part of their oral caloric intake. M-MILK is provided by research nurses or parents.
Other: Multisensory early oral administration of human milk
Infants in the Control group will receive standard of care.
M-MILK is implemented starting on day 3 of life, during the day shift, after every hands-on care, during the beginning of a full gavage feeding, and up to 4 times a day. Infants receive M-MILK in small droplets via a 1-ml syringe. M-MILK will cease upon oral feeding initiation. Infants will receive either mother's own milk or donor's milk based on availability. Infants may receive up to 1 mL of milk each time based on their cues and responses. The 1 mL volume intake is included as part of their oral caloric intake. M-MILK is provided by research nurses or parents.
Also known as: M-MILK
Oral feeding Skills: EFS assessment total score at PO Initiation
We will evaluate oral feeding skills using the Early Feeding Skills Assessment (EFS) at oral feeding (PO) initiation. The EFS provides a summary score for each of the 5 subscale (respiratory regulation, oral-motor functioning, swallowing coordination, engagement, and physiologic stability), as well as a total summary score. Higher EFS summary scores indicate more competent oral feeding skills.
Time frame: Up to 12 weeks after birth.
Oral Feeding Skills: EFS assessment total score at 36 Weeks PMA
We will evaluate oral feeding skills using the Early Feeding Skills Assessment (EFS) at 36 weeks post-menstrual age (PMA). The EFS provides a summary score for each of the 5 subscale (respiratory regulation, oral-motor functioning, swallowing coordination, engagement, and physiologic stability), as well as a total summary score. Higher EFS summary scores indicate more competent oral feeding skills.
Time frame: 36 weeks postmenstrual age.
Stress Regulation: Salivary Cortisol at PO Initiation
We will evaluate stress regulation, measured by salivary cortisol levels (μg/dL) at oral feeding (PO) initiation.
Time frame: Up to 12 weeks after birth.
Stress Regulation: Salivary Cortisol at 36 Weeks PMA
We will evaluate stress regulation, measured by salivary cortisol levels (μg/dL) at 36 weeks PMA.
Time frame: At 36 weeks postmenstrual age.
Stress Regulation: Buccal Cell DNAm of NR3C1 Exon 1F Promoter at PO Initiation
We will evaluate stress regulation, measured by buccal cell DNA methylation (DNAm) of NR3C1 Exon 1F promoter at oral feeding (PO) initiation. We anticipate to cover 33 CpG sites within the NR3C1 Exon 1F promoter. Methylation percentage (%) will calculated per CpG site (aligning with the human reference genome hg38).
Time frame: Up to 12 weeks after birth.
Stress Regulation: Buccal Cell DNAm of NR3C1 Exon 1F Promoter at 36 Weeks PMA
We will evaluate stress regulation, measured by buccal cell DNA methylation (DNAm) of NR3C1 Exon 1F promoter at 36 weeks post-menstrual age (PMA). We anticipate to cover 33 CpG sites within the NR3C1 Exon 1F promoter. Methylation percentage (%) will calculated per CpG site (aligning with the human reference genome hg38).
Time frame: At 36 weeks postmenstrual age.
Stress Regulation: Buccal Cell DNAm of HSD11B2 Promoter at PO Initiation
We will evaluate stress regulation, measured by buccal cell DNA methylation (DNAm) of HSD11B2 promoter at oral feeding (PO) initiation. We anticipate to cover 30 CpG sites within the HSD11B2 promoter. Methylation percentage (%) will calculated per CpG site (aligning with the human reference genome hg38).
Time frame: Up to 12 weeks after birth.
Stress Regulation: Buccal Cell DNAm of HSD11B2 Promoter at 36 Weeks PMA
We will evaluate stress regulation, measured by buccal cell DNA methylation (DNAm) of HSD11B2 promoter at 36 weeks post-menstrual age (PMA). We anticipate to cover 30 CpG sites within the HSD11B2 promoter. Methylation percentage (%) will calculated per CpG site (aligning with the human reference genome hg38).
Time frame: At 36 weeks postmenstrual age.
Neurodevelopment: NNNS-II Attention score 36 Weeks PMA
We will evaluate neurodevelopment using the NeoNatal Neurobehavioral Scale (NNNS-II) at 36 weeks post-menstrual age (PMA). The NNNS-II provides a summary score for each of the 13 domain (attention, handling, self-regulation, habituation, arousal, excitability, lethargy, hypertonicity, hypotonicity, nonoptimal reflexes, asymmetric reflexes, quality of movement, and stress/abstinence). High-risk neurodevelopment is characterized by higher scores in handling, arousal, excitability, lethargy, hypertonicity, hypotonicity, nonoptimal reflexes, asymmetric reflexes, and stress/abstinence, along with lower score in quality of movement, attention, self-regulation, habituation. Low-risk neurodevelopment is characterized by higher scores in attention, self-regulation, habituation, and quality of movement, along with lower scores in handling, arousal, excitability, lethargy, hypertonicity, hypotonicity, nonoptimal reflexes, asymmetric reflexes, and stress/abstinence.
Time frame: At 36 weeks postmenstrual age.
Neurodevelopment: NNNS-II Handling score 36 Weeks PMA
We will evaluate neurodevelopment using the NeoNatal Neurobehavioral Scale (NNNS-II) at 36 weeks post-menstrual age (PMA). The NNNS-II provides a summary score for each of the 13 domain (attention, handling, self-regulation, habituation, arousal, excitability, lethargy, hypertonicity, hypotonicity, nonoptimal reflexes, asymmetric reflexes, quality of movement, and stress/abstinence). High-risk neurodevelopment is characterized by higher scores in handling, arousal, excitability, lethargy, hypertonicity, hypotonicity, nonoptimal reflexes, asymmetric reflexes, and stress/abstinence, along with lower score in quality of movement, attention, self-regulation, habituation. Low-risk neurodevelopment is characterized by higher scores in attention, self-regulation, habituation, and quality of movement, along with lower scores in handling, arousal, excitability, lethargy, hypertonicity, hypotonicity, nonoptimal reflexes, asymmetric reflexes, and stress/abstinence.
Time frame: At 36 weeks postmenstrual age.
Neurodevelopment: NNNS-II Self-Regulation 36 Weeks PMA
We will evaluate neurodevelopment using the NeoNatal Neurobehavioral Scale (NNNS-II) at 36 weeks post-menstrual age (PMA). The NNNS-II provides a summary score for each of the 13 domain (attention, handling, self-regulation, habituation, arousal, excitability, lethargy, hypertonicity, hypotonicity, nonoptimal reflexes, asymmetric reflexes, quality of movement, and stress/abstinence). High-risk neurodevelopment is characterized by higher scores in handling, arousal, excitability, lethargy, hypertonicity, hypotonicity, nonoptimal reflexes, asymmetric reflexes, and stress/abstinence, along with lower score in quality of movement, attention, self-regulation, habituation. Low-risk neurodevelopment is characterized by higher scores in attention, self-regulation, habituation, and quality of movement, along with lower scores in handling, arousal, excitability, lethargy, hypertonicity, hypotonicity, nonoptimal reflexes, asymmetric reflexes, and stress/abstinence.
Time frame: At 36 weeks postmenstrual age.
Neurodevelopment: NNNS-II Habituation score 36 Weeks PMA
We will evaluate neurodevelopment using the NeoNatal Neurobehavioral Scale (NNNS-II) at 36 weeks post-menstrual age (PMA). The NNNS-II provides a summary score for each of the 13 domain (attention, handling, self-regulation, habituation, arousal, excitability, lethargy, hypertonicity, hypotonicity, nonoptimal reflexes, asymmetric reflexes, quality of movement, and stress/abstinence). High-risk neurodevelopment is characterized by higher scores in handling, arousal, excitability, lethargy, hypertonicity, hypotonicity, nonoptimal reflexes, asymmetric reflexes, and stress/abstinence, along with lower score in quality of movement, attention, self-regulation, habituation. Low-risk neurodevelopment is characterized by higher scores in attention, self-regulation, habituation, and quality of movement, along with lower scores in handling, arousal, excitability, lethargy, hypertonicity, hypotonicity, nonoptimal reflexes, asymmetric reflexes, and stress/abstinence.
Time frame: At 36 weeks postmenstrual age.
Neurodevelopment: NNNS-II Arousal score 36 Weeks PMA
We will evaluate neurodevelopment using the NeoNatal Neurobehavioral Scale (NNNS-II) at 36 weeks post-menstrual age (PMA). The NNNS-II provides a summary score for each of the 13 domain (attention, handling, self-regulation, habituation, arousal, excitability, lethargy, hypertonicity, hypotonicity, nonoptimal reflexes, asymmetric reflexes, quality of movement, and stress/abstinence). High-risk neurodevelopment is characterized by higher scores in handling, arousal, excitability, lethargy, hypertonicity, hypotonicity, nonoptimal reflexes, asymmetric reflexes, and stress/abstinence, along with lower score in quality of movement, attention, self-regulation, habituation. Low-risk neurodevelopment is characterized by higher scores in attention, self-regulation, habituation, and quality of movement, along with lower scores in handling, arousal, excitability, lethargy, hypertonicity, hypotonicity, nonoptimal reflexes, asymmetric reflexes, and stress/abstinence.
Time frame: At 36 weeks postmenstrual age.
Neurodevelopment: NNNS-II Excitability score 36 Weeks PMA
We will evaluate neurodevelopment using the NeoNatal Neurobehavioral Scale (NNNS-II) at 36 weeks post-menstrual age (PMA). The NNNS-II provides a summary score for each of the 13 domain (attention, handling, self-regulation, habituation, arousal, excitability, lethargy, hypertonicity, hypotonicity, nonoptimal reflexes, asymmetric reflexes, quality of movement, and stress/abstinence). High-risk neurodevelopment is characterized by higher scores in handling, arousal, excitability, lethargy, hypertonicity, hypotonicity, nonoptimal reflexes, asymmetric reflexes, and stress/abstinence, along with lower score in quality of movement, attention, self-regulation, habituation. Low-risk neurodevelopment is characterized by higher scores in attention, self-regulation, habituation, and quality of movement, along with lower scores in handling, arousal, excitability, lethargy, hypertonicity, hypotonicity, nonoptimal reflexes, asymmetric reflexes, and stress/abstinence.
Time frame: At 36 weeks postmenstrual age.
Neurodevelopment: NNNS-II Lethargy score 36 Weeks PMA
We will evaluate neurodevelopment using the NeoNatal Neurobehavioral Scale (NNNS-II) at 36 weeks post-menstrual age (PMA). The NNNS-II provides a summary score for each of the 13 domain (attention, handling, self-regulation, habituation, arousal, excitability, lethargy, hypertonicity, hypotonicity, nonoptimal reflexes, asymmetric reflexes, quality of movement, and stress/abstinence). High-risk neurodevelopment is characterized by higher scores in handling, arousal, excitability, lethargy, hypertonicity, hypotonicity, nonoptimal reflexes, asymmetric reflexes, and stress/abstinence, along with lower score in quality of movement, attention, self-regulation, habituation. Low-risk neurodevelopment is characterized by higher scores in attention, self-regulation, habituation, and quality of movement, along with lower scores in handling, arousal, excitability, lethargy, hypertonicity, hypotonicity, nonoptimal reflexes, asymmetric reflexes, and stress/abstinence.
Time frame: At 36 weeks postmenstrual age.
Neurodevelopment: NNNS-II Hypertonicity score 36 Weeks PMA
We will evaluate neurodevelopment using the NeoNatal Neurobehavioral Scale (NNNS-II) at 36 weeks post-menstrual age (PMA). The NNNS-II provides a summary score for each of the 13 domain (attention, handling, self-regulation, habituation, arousal, excitability, lethargy, hypertonicity, hypotonicity, nonoptimal reflexes, asymmetric reflexes, quality of movement, and stress/abstinence). High-risk neurodevelopment is characterized by higher scores in handling, arousal, excitability, lethargy, hypertonicity, hypotonicity, nonoptimal reflexes, asymmetric reflexes, and stress/abstinence, along with lower score in quality of movement, attention, self-regulation, habituation. Low-risk neurodevelopment is characterized by higher scores in attention, self-regulation, habituation, and quality of movement, along with lower scores in handling, arousal, excitability, lethargy, hypertonicity, hypotonicity, nonoptimal reflexes, asymmetric reflexes, and stress/abstinence.
Time frame: At 36 weeks postmenstrual age.
Neurodevelopment: NNNS-II Hypotonicity score 36 Weeks PMA
We will evaluate neurodevelopment using the NeoNatal Neurobehavioral Scale (NNNS-II) at 36 weeks post-menstrual age (PMA). The NNNS-II provides a summary score for each of the 13 domain (attention, handling, self-regulation, habituation, arousal, excitability, lethargy, hypertonicity, hypotonicity, nonoptimal reflexes, asymmetric reflexes, quality of movement, and stress/abstinence). High-risk neurodevelopment is characterized by higher scores in handling, arousal, excitability, lethargy, hypertonicity, hypotonicity, nonoptimal reflexes, asymmetric reflexes, and stress/abstinence, along with lower score in quality of movement, attention, self-regulation, habituation. Low-risk neurodevelopment is characterized by higher scores in attention, self-regulation, habituation, and quality of movement, along with lower scores in handling, arousal, excitability, lethargy, hypertonicity, hypotonicity, nonoptimal reflexes, asymmetric reflexes, and stress/abstinence.
Time frame: At 36 weeks postmenstrual age.
Neurodevelopment: NNNS-II Nonoptimal Reflexes score 36 Weeks PMA
We will evaluate neurodevelopment using the NeoNatal Neurobehavioral Scale (NNNS-II) at 36 weeks post-menstrual age (PMA). The NNNS-II provides a summary score for each of the 13 domain (attention, handling, self-regulation, habituation, arousal, excitability, lethargy, hypertonicity, hypotonicity, nonoptimal reflexes, asymmetric reflexes, quality of movement, and stress/abstinence). High-risk neurodevelopment is characterized by higher scores in handling, arousal, excitability, lethargy, hypertonicity, hypotonicity, nonoptimal reflexes, asymmetric reflexes, and stress/abstinence, along with lower score in quality of movement, attention, self-regulation, habituation. Low-risk neurodevelopment is characterized by higher scores in attention, self-regulation, habituation, and quality of movement, along with lower scores in handling, arousal, excitability, lethargy, hypertonicity, hypotonicity, nonoptimal reflexes, asymmetric reflexes, and stress/abstinence.
Time frame: At 36 weeks postmenstrual age.
Neurodevelopment: NNNS-II Asymmetric Reflexes score 36 Weeks PMA
We will evaluate neurodevelopment using the NeoNatal Neurobehavioral Scale (NNNS-II) at 36 weeks post-menstrual age (PMA). The NNNS-II provides a summary score for each of the 13 domain (attention, handling, self-regulation, habituation, arousal, excitability, lethargy, hypertonicity, hypotonicity, nonoptimal reflexes, asymmetric reflexes, quality of movement, and stress/abstinence). High-risk neurodevelopment is characterized by higher scores in handling, arousal, excitability, lethargy, hypertonicity, hypotonicity, nonoptimal reflexes, asymmetric reflexes, and stress/abstinence, along with lower score in quality of movement, attention, self-regulation, habituation. Low-risk neurodevelopment is characterized by higher scores in attention, self-regulation, habituation, and quality of movement, along with lower scores in handling, arousal, excitability, lethargy, hypertonicity, hypotonicity, nonoptimal reflexes, asymmetric reflexes, and stress/abstinence.
Time frame: At 36 weeks postmenstrual age.
Neurodevelopment: NNNS-II Quality of Movement score 36 Weeks PMA
We will evaluate neurodevelopment using the NeoNatal Neurobehavioral Scale (NNNS-II) at 36 weeks post-menstrual age (PMA). The NNNS-II provides a summary score for each of the 13 domain (attention, handling, self-regulation, habituation, arousal, excitability, lethargy, hypertonicity, hypotonicity, nonoptimal reflexes, asymmetric reflexes, quality of movement, and stress/abstinence). High-risk neurodevelopment is characterized by higher scores in handling, arousal, excitability, lethargy, hypertonicity, hypotonicity, nonoptimal reflexes, asymmetric reflexes, and stress/abstinence, along with lower score in quality of movement, attention, self-regulation, habituation. Low-risk neurodevelopment is characterized by higher scores in attention, self-regulation, habituation, and quality of movement, along with lower scores in handling, arousal, excitability, lethargy, hypertonicity, hypotonicity, nonoptimal reflexes, asymmetric reflexes, and stress/abstinence.
Time frame: At 36 weeks postmenstrual age.
Neurodevelopment: NNNS-II Stress/Abstinence score 36 Weeks PMA
We will evaluate neurodevelopment using the NeoNatal Neurobehavioral Scale (NNNS-II) at 36 weeks post-menstrual age (PMA). The NNNS-II provides a summary score for each of the 13 domain (attention, handling, self-regulation, habituation, arousal, excitability, lethargy, hypertonicity, hypotonicity, nonoptimal reflexes, asymmetric reflexes, quality of movement, and stress/abstinence). High-risk neurodevelopment is characterized by higher scores in handling, arousal, excitability, lethargy, hypertonicity, hypotonicity, nonoptimal reflexes, asymmetric reflexes, and stress/abstinence, along with lower score in quality of movement, attention, self-regulation, habituation. Low-risk neurodevelopment is characterized by higher scores in attention, self-regulation, habituation, and quality of movement, along with lower scores in handling, arousal, excitability, lethargy, hypertonicity, hypotonicity, nonoptimal reflexes, asymmetric reflexes, and stress/abstinence.
Time frame: At 36 weeks postmenstrual age.
Oral Feeding Skills: EFS assessment score for Respiratory Regulation at PO Initiation
We will evaluate oral feeding skills using the Early Feeding Skills Assessment (EFS) at oral feeding (PO) initiation. The EFS provides a summary score for each of the 5 subscale (respiratory regulation, oral-motor functioning, swallowing coordination, engagement, and physiologic stability), as well as a total summary score. Higher EFS summary scores indicate more competent oral feeding skills.
Time frame: Up to 12 weeks after birth.
Oral Feeding Skills: EFS assessment score for Oral-motor Functioning at PO Initiation
We will evaluate oral feeding skills using the Early Feeding Skills Assessment (EFS) at oral feeding (PO) initiation. The EFS provides a summary score for each of the 5 subscale (respiratory regulation, oral-motor functioning, swallowing coordination, engagement, and physiologic stability), as well as a total summary score. Higher EFS summary scores indicate more competent oral feeding skills.
Time frame: Up to 12 weeks after birth.
Oral Feeding Skills: EFS assessment score for Swallowing Coordination at PO Initiation
We will evaluate oral feeding skills using the Early Feeding Skills Assessment (EFS) at oral feeding (PO) initiation. The EFS provides a summary score for each of the 5 subscale (respiratory regulation, oral-motor functioning, swallowing coordination, engagement, and physiologic stability), as well as a total summary score. Higher EFS summary scores indicate more competent oral feeding skills.
Time frame: Up to 12 weeks after birth.
Oral Feeding Skills: EFS assessment score for Engagement at PO Initiation
We will evaluate oral feeding skills using the Early Feeding Skills Assessment (EFS) at oral feeding (PO) initiation. The EFS provides a summary score for each of the 5 subscale (respiratory regulation, oral-motor functioning, swallowing coordination, engagement, and physiologic stability), as well as a total summary score. Higher EFS summary scores indicate more competent oral feeding skills.
Time frame: Up to 12 weeks after birth.
Oral Feeding Skills: EFS assessment score for Physiologic Stability at PO Initiation
We will evaluate oral feeding skills using the Early Feeding Skills Assessment (EFS) at oral feeding (PO) initiation. The EFS provides a summary score for each of the 5 subscale (respiratory regulation, oral-motor functioning, swallowing coordination, engagement, and physiologic stability), as well as a total summary score. Higher EFS summary scores indicate more competent oral feeding skills.
Time frame: Up to 12 weeks after birth.
Oral Feeding Skills: EFS assessment score for Respiratory Regulation at 36 Weeks PMA
We will evaluate oral feeding skills using the Early Feeding Skills Assessment (EFS) at 36 weeks PMA. The EFS provides a summary score for each of the 5 subscale (respiratory regulation, oral-motor functioning, swallowing coordination, engagement, and physiologic stability), as well as a total summary score. Higher EFS summary scores indicate more competent oral feeding skills.
Time frame: At 36 weeks postmenstrual age.
Oral Feeding Skills: EFS assessment score for Oral-motor Functioning at 36 Weeks PMA
We will evaluate oral feeding skills using the Early Feeding Skills Assessment (EFS) at 36 weeks PMA. The EFS provides a summary score for each of the 5 subscale (respiratory regulation, oral-motor functioning, swallowing coordination, engagement, and physiologic stability), as well as a total summary score. Higher EFS summary scores indicate more competent oral feeding skills.
Time frame: At 36 weeks postmenstrual age.
Oral Feeding Skills: EFS assessment score for Swallowing Coordination at 36 Weeks PMA
We will evaluate oral feeding skills using the Early Feeding Skills Assessment (EFS) at 36 weeks PMA. The EFS provides a summary score for each of the 5 subscale (respiratory regulation, oral-motor functioning, swallowing coordination, engagement, and physiologic stability), as well as a total summary score. Higher EFS summary scores indicate more competent oral feeding skills.
Time frame: At 36 weeks postmenstrual age.
Oral Feeding Skills: EFS assessment score for Engagement at 36 Weeks PMA
We will evaluate oral feeding skills using the Early Feeding Skills Assessment (EFS) at 36 weeks PMA. The EFS provides a summary score for each of the 5 subscale (respiratory regulation, oral-motor functioning, swallowing coordination, engagement, and physiologic stability), as well as a total summary score. Higher EFS summary scores indicate more competent oral feeding skills.
Time frame: At 36 weeks postmenstrual age.
Oral Feeding Skills: EFS assessment score for Physiologic Stability at 36 Weeks PMA
We will evaluate oral feeding skills using the Early Feeding Skills Assessment (EFS) at 36 weeks PMA. The EFS provides a summary score for each of the 5 subscale (respiratory regulation, oral-motor functioning, swallowing coordination, engagement, and physiologic stability), as well as a total summary score. Higher EFS summary scores indicate more competent oral feeding skills.
Time frame: At 36 weeks postmenstrual age.
Oral Feeding Skills: NeoEAT Total score at 2 Months CA
We will evaluate oral feeding skills using the Neonatal Eating Assessment Tool (NeoEAT-Bottle-feeding) at 2 months corrected age (CA). The NeoEAT-Bottle-feeding provides a summary score for each of the 5 subscale (regulation, energy and physiologic stability, gastrointestinal tract function, sensory responsiveness, and compelling symptoms of problematic feeding) and a total summary score. Lower NeoEAT-Bottle-feeding summary scores indicate more competent oral feeding skills.
Time frame: At 2 months corrected age.
Oral Feeding Skills: NeoEAT score for Regulation at 2 Months CA
We will evaluate oral feeding skills using the Neonatal Eating Assessment Tool (NeoEAT-Bottle-feeding) at 2 months corrected age (CA). The NeoEAT-Bottle-feeding provides a summary score for each of the 5 subscale (regulation, energy and physiologic stability, gastrointestinal tract function, sensory responsiveness, and compelling symptoms of problematic feeding) and a total summary score. Lower NeoEAT-Bottle-feeding summary scores indicate more competent oral feeding skills.
Time frame: At 2 months corrected age.
Oral Feeding Skills: NeoEAT score for Energy and Physiologic Stability at 2 Months CA
We will evaluate oral feeding skills using the Neonatal Eating Assessment Tool (NeoEAT-Bottle-feeding) at 2 months corrected age (CA). The NeoEAT-Bottle-feeding provides a summary score for each of the 5 subscale (regulation, energy and physiologic stability, gastrointestinal tract function, sensory responsiveness, and compelling symptoms of problematic feeding) and a total summary score. Lower NeoEAT-Bottle-feeding summary scores indicate more competent oral feeding skills.
Time frame: At 2 months corrected age.
Oral Feeding Skills: NeoEAT score for Gastrointestinal Tract Function at 2 Months CA
We will evaluate oral feeding skills using the Neonatal Eating Assessment Tool (NeoEAT-Bottle-feeding) at 2 months corrected age (CA). The NeoEAT-Bottle-feeding provides a summary score for each of the 5 subscale (regulation, energy and physiologic stability, gastrointestinal tract function, sensory responsiveness, and compelling symptoms of problematic feeding) and a total summary score. Lower NeoEAT-Bottle-feeding summary scores indicate more competent oral feeding skills.
Time frame: At 2 months corrected age.
Oral Feeding Skills: NeoEAT score for Sensory Responsiveness at 2 Months CA
We will evaluate oral feeding skills using the Neonatal Eating Assessment Tool (NeoEAT-Bottle-feeding) at 2 months corrected age (CA). The NeoEAT-Bottle-feeding provides a summary score for each of the 5 subscale (regulation, energy and physiologic stability, gastrointestinal tract function, sensory responsiveness, and compelling symptoms of problematic feeding) and a total summary score. Lower NeoEAT-Bottle-feeding summary scores indicate more competent oral feeding skills.
Time frame: At 2 months corrected age.
Oral Feeding Skills: NeoEAT score for Compelling Symptoms of Problematic Feeding at 2 Months CA
We will evaluate oral feeding skills using the Neonatal Eating Assessment Tool (NeoEAT-Bottle-feeding) at 2 months corrected age (CA). The NeoEAT-Bottle-feeding provides a summary score for each of the 5 subscale (regulation, energy and physiologic stability, gastrointestinal tract function, sensory responsiveness, and compelling symptoms of problematic feeding) and a total summary score. Lower NeoEAT-Bottle-feeding summary scores indicate more competent oral feeding skills.
Time frame: At 2 months corrected age.
Neurodevelopment: ASQ-3 Communication score at 2 Months CA
We will evaluate neurodevelopment using the Ages and Stages Questionnaire (ASQ-3) at 2 months corrected age (CA). The 2-month ASQ-3 provides a summary score for each of the 3 domain (communication, gross motor, and personal-social skills). Higher summary scores indicate more optimal neurodevelopment.
Time frame: At 2 months corrected age.
Neurodevelopment: ASQ-3 Gross Motor score at 2 Months CA
We will evaluate neurodevelopment using the Ages and Stages Questionnaire (ASQ-3) at 2 months corrected age (CA). The 2-month ASQ-3 provides a summary score for each of the 3 domain (communication, gross motor, and personal-social skills). Higher summary scores indicate more optimal neurodevelopment.
Time frame: At 2 months corrected age.
Neurodevelopment: ASQ-3 Personal-Social Skills score at 2 Months CA
We will evaluate neurodevelopment using the Ages and Stages Questionnaire (ASQ-3) at 2 months corrected age (CA). The 2-month ASQ-3 provides a summary score for each of the 3 domain (communication, gross motor, and personal-social skills). Higher summary scores indicate more optimal neurodevelopment.
Time frame: At 2 months corrected age.
Plan to share: No — We do not plan to share IPD to ensure confidentiality and privacy participants. We have plans to share only de-identifiable data. Data will be shared in accordance with the NIH Data Sharing Policy. Data will be shared on reasonable request to Loyola University Chicago through a Data Use Agreement (DUA).
Started Nov 2025 (actual). Primary completion is estimated for May 2030, 54 months after the start.
Of 33 non-industry interventional studies with no phase under Infant, Premature, Diseases, half reached primary completion within 19 months of starting (the median), counting those still running; a quarter within 11 and three quarters within 29. This study's planned 54 months is above that.
Counting every sponsor, half of 33 studies reached it within 19 months; a quarter within 11 and three quarters within 29.
How these figures are worked out, and which studies are left out of them.
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