Effectiveness of Family-Integrated Newborn Care to Improve Outcomes for Preterm and Low-birth-weight Neonates

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• Empowerment 154

Empowerment

154 studies on the registry are indexed under Empowerment; 31 are open to participants now.

This study's planned enrollment of 1,020 is above the median of 141 across 132 interventional studies indexed under Empowerment.

Lead sponsor

This is the only study on the registry with Laerdal Foundation as lead sponsor.

Study arms

• Experimental
  FINC arm

  This arm includes the family of the neonates assigned to the experimental group, and they will receive a FINC intervention. The FINC intervention, families of preterm and low-birth weight neonates aged 0-28 days will be trained, educated, and encouraged to get involved in the newborn care targeted to their neonates.

  Behavioral: Family Integrated Newborn Care, an intervention to integrate family in the care targeted their preterm and Low-birth weight neonates

• Active comparator
  Non-FINC arm

  This arm includes the families of the neonates assigned to the comparator group, who will receive conventional or standard care. No special effort that the routine care will be provided to integrate the family into the care targeted to the preterm and low-birth-weight neonates

  Behavioral: Standard medical treatment

Interventions

• BehavioralFamily Integrated Newborn Care, an intervention to integrate family in the care targeted their preterm and Low-birth weight neonates

  The Family Integrated Newborn Care intervention includes undergoing 1) minor modifications in the NCU space and physical infrastructure conducive to family integration; 2) bedside training for families, and 3) provision of ten audio-visual materials in the local language (Tigrigna) demonstrating family integration in key caring activities targeted to their neonates.

  Also known as: Family-Centered care, Family Involvement

• BehavioralStandard medical treatment

  The preterm and low-birth weight neonates will receive the conventional care with no special attention to integrate the families in the care targeted to the neonates

  Also known as: Conventional newborn care

Primary outcomes

1. Length of hospital stay

   It refers to the duration a neonate stays in the hospital for care, starting from admission to discharge home

   Time frame: The period from the date of admission to the date of discharge is within the first 28 days of neonat's life.

Secondary outcomes

1. Survival at discharge

   Survival status of the neonate at discharge, specified as alive, dead, or referred for higher-level care, or left against medical advice.

   Time frame: Starting from date of admission to the date of discharge within the first 28 days of the neonate's life

2. Daily weight gain

   The net weight gain of a neonate each day (in grams/kg/day) in reference to the expected gain for the body mass

   Time frame: Starting from the date of admission up to the date of discharge and assessed in the first 28 days of the neonate's life

3. Time to initiate breastfeeding after admission

   The time the breastfeeding of the neonate is initiated for the first time since admission

   Time frame: Starting from the date of admission to the date of discharge, within the first 28 days of the neonate's life

4. Time to initiate skin-to-skin after admission

   The first time skin-to-skin is initiated for the neonate, since the date of admission to the Neonatal Intensive Care Unit (NICU)

   Time frame: Starting from the date of admission to the date of discharge, within the first 28 days of the neonate's life

5. The number of days on Antibiotics

   The total number of days the neonate received antibiotics for being suspected or diagnosed with sepsis

   Time frame: Starting from the date of admission to the date of discharge, within the first 28 days of the neonate's life

6. Score for parental stress monitoring scale

   A score for the parental stress monitoring scale, which consists of eight items in a five-point Likert scale, with scores ranging from a lower score (1= Not stressful at all) to a higher score (5= Extremely stressful).

   Time frame: Starting from the date of admission to the date of discharge, within the first 28 days of the neonate's life

7. Discharge readiness score on the day of the discharge

   The score for the discharge readiness scale, consisting of eight items in a five-point Likert scale, to assess parents' readiness at the time of discharge. The score level ranges from a lower score (1= Extremely low confidence) to a higher score (5= Extremely high confidence).

   Time frame: Starting from the date of admission to the date of discharge, within the first 28 days of the neonate's life

Publications

• Kahsay ZH, Medhanyie AA, Mariam DH, Ersdal HL, Rettedal S. Feasibility of implementing family-integrated newborn care for hospitalised preterm and low birthweight infants in newborn care units of Ethiopia: a mixed-methods design. BMJ Open. 2025 Jan 21;15(1):e093377. doi: 10.1136/bmjopen-2024-093377. PubMed 39842933 ↗

Individual participant data

Plan to share: Yes — The study is part of a PhD study. The dataset consists of inpatient data will be shared after the manuscript summarizing the key findings of the trial is published. Hence, the dataset will be made available open for the public in June 2027. In addition, the IPD can be shared up on reasonable request form the contact person of the study.

Supporting information: Study protocol, Statistical analysis plan, Informed consent form, Clinical study report

Time frame: June 2027, one year after the completion of the trial

Access criteria: The IPD will be available in the data repository for Mekelle University based on the notification to the contact person of the study

Data sharing details ↗ · repository.mu.edu.et