An interventional study of Arm 1 - Side-lying position followed by Supine position and Arm 2 - Supine position followed by Side-lying position in Feeding, Bottle, Infant, Premature, Diseases and Behavior, Infant, sponsored by Boston College. Completed at 1 site in United States. Open to participants aged Up to 2 Months. Per ClinicalTrials.gov, last updated 2024-07-12.
Sponsored by Boston College · Not applicable, Interventional, and Supportive care
The objective of the proposed research is to conduct a within-subject cross-over trial that will compare the efficacy of the two bottle-feeding positions on physiologic and behavioral responses of preterm infants prior to, during, and after feeding. As an exploratory aim, the investigators will also identify potential infant characteristics associated with the intervention response by evaluating infant sex, maturity level, and/or comorbidity. The two bottle-feeding positions will be the semi-elevated side-lying position (hereafter referred to as side-lying position) and the semi-elevated supine position (hereafter referred to as supine position), which is the traditional feeding position when preterm infants are bottle-fed. The investigators hypothesize that compared to the supine position, the side-lying position will be associated with greater physiologic stability in heart rate, respiratory rate, oxygen saturation, and/or autonomic nervous system regulation during and after feeding. The investigators also hypothesize that compared to the supine position, the side-lying position will be associated with more mature patterns of suck-breathe coordination and/or greater feeding skills.
100 studies on the registry are indexed under Infant, Premature, Diseases; 16 are open to participants now.
This study's enrollment of 60 is close to the median of 62 across 64 interventional studies indexed under Infant, Premature, Diseases.
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Exclusion Criteria:
In this arm, infants will be bottle-fed in the side-lying position first followed by the supine position.
Other: Arm 1 - Side-lying position followed by Supine position
In this arm, infants will be bottle-fed in the supine position first followed by the side-lying position.
Other: Arm 2 - Supine position followed by Side-lying position
Infants will be observed for two bottle feedings within a 24-hour period when they reach approximately 30-50% oral feeding. In this arm, infants will be bottle-fed in the side-lying position first followed by the supine position. In the side-lying feeding position, the infant will be placed on the caregiver's lap with one ear and hip facing the ceiling at a 45 to 60 degree angle. In the supine feeding position, the infant will be placed facing the caregiver in a reclining position at a 45 to 60 degree angle. In both feeding positions, the infant's head, neck, and upper body will be supported by the caregiver to maintain a neutral straight alignment with the chin tilted down slightly without the neck being extended or in excessive flexion. The infant will also be loosely swaddled with a single blanket so their legs, shoulders, and elbows are supported in a flexed position but with the lower arms free to move.
Infants will be observed for two bottle feedings within a 24-hour period when they reach approximately 30-50% oral feeding. In this arm, infants will be bottle-fed in the supine position first followed by the side-lying position. In the side-lying feeding position, the infant will be placed on the caregiver's lap with one ear and hip facing the ceiling at a 45 to 60 degree angle. In the supine feeding position, the infant will be placed facing the caregiver in a reclining position at a 45 to 60 degree angle. In both feeding positions, the infant's head, neck, and upper body will be supported by the caregiver to maintain a neutral straight alignment with the chin tilted down slightly without the neck being extended or in excessive flexion. The infant will also be loosely swaddled with a single blanket so their legs, shoulders, and elbows are supported in a flexed position but with the lower arms free to move.
Infant physiologic responses to the feeding position - Heart rate (HR)
HR will be measured for 30 minutes pre-feeding (baseline), feeding, and 30 minutes post-feeding (recovery).
Time frame: Up to 30 minutes post-feeding
Infant physiologic responses to the feeding position - Respiratory rate (RR)
RR will be measured for 30 minutes pre-feeding (baseline), feeding, and 30 minutes post-feeding (recovery).
Time frame: Up to 30 minutes post-feeding
Infant physiologic responses to the feeding position - Oxygen saturation (SaO2)
SaO2 will be measured for 30 minutes pre-feeding (baseline), feeding, and 30 minutes post-feeding (recovery).
Time frame: Up to 30 minutes post-feeding
Infant physiologic responses to the feeding position - Heart rate variability (HRV)
HRV will be measured for 30 minutes pre-feeding (baseline), feeding, and 30 minutes post-feeding (recovery).
Time frame: Up to 30 minutes post-feeding
Infant physiologic responses to the feeding position - Splanchnic-cerebral oxygen ratio (SCOR)
SCOR will be measured for 30 minutes pre-feeding (baseline), feeding, and 30 minutes post-feeding (recovery).
Time frame: Up to 30 minutes post-feeding
Infant behavioral responses to the feeding position - Suck-breathe coordination
Infant behavioral responses will be assessed by the behavioral observation of suck-breathe coordination patterns using Suck-Breath Coordination coding scheme.
Time frame: 5-30 minutes post-baseline
Infant behavioral responses to the feeding position - Infant feeding skill
Infant behavioral responses will be assessed by the behavioral observation of infant feeding skill using the Early Feeding Skills (EFS) assessment tool.
Time frame: 5-30 minutes post-baseline
Infant characteristics associated with the intervention response - Infant's sex
Infant's sex (female vs. male)
Time frame: At enrollment
Infant characteristics associated with the intervention response - Maturity level
Maturity level will be assessed by gestational age at birth
Time frame: At enrollment
Infant characteristics associated with the intervention response - Maturity level
Maturity level will be assessed by postmenstrual age at the time of study
Time frame: At the end of the feeding observation, up to 30 minutes post-feeding
Infant characteristics associated with the intervention response - Overall severity of illness
Overall severity illness score will be calculated using the Neonatal Medical Index (range of 1 \[least severe\] to 5 \[most severe\])
Time frame: At discharge, up to 150 days
Infant characteristics associated with the intervention response - Severity of lung disease
Severity of lung disease will be assessed using diagnostic criteria of bronchopulmonary dysplasia (none, mild, moderate, or severe)
Time frame: At discharge, up to 150 days
Plan to share: Yes — A database will be established to store project data. This data will be free of identifiers that would permit linkages to individual research participants and variables that could lead to deductive disclosure of the identity of individual subjects. Presentations, abstracts, and manuscripts related to the work will also be centrally stored. Once the project is finished and all analyses are complete, it is our intention to make the study dataset available upon request.
Supporting information: Study protocol, Sap, Icf, Csr, Analytic code
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This study is completed, as verified in Jul 2024. You cannot join it, but the record below documents what was studied.
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