A family support program for premature babies and their parents to improve baby growth, development and reduced parental stress ;a study in Odisha , India

Effectiveness of Family-Based Intervention Program (FBIP) on infant growth parameters and development, parent-child interaction, and parental stress in neonates: A randomised controlled trial. - FBIP-RCT

Status

Active, not recruiting

Phases

Phase 2Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2026/03/106872

Enrollment

144

Registered

2026-03-25

Start date

Unknown

Completion date

Unknown

Last updated

2026-03-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Intervention1: family based intervention programme: modules, session with videos and photos ,demonstration Intervention2: family based intervention programme.: The Family-Based Intervention Program (F

Eligibility

Inclusion criteria

Inclusion criteria: Parents who: Can read and understand Odia or English for effective communication Are willing to participate in all intervention phases and provide informed consent. Reside in Bhubaneswar or nearby areas to ensure better follow-up and reduce dropout rates. Have not previously participated in a similar intervention program. Neonates who: Have a gestational age of 32 to 34 weeks at birth. They are admitted to the NICU of the selected tertiary care hospital. Minimum hospital stays 4 to 6 weeks and maximum 10weeks.

Exclusion criteria

Exclusion criteria: Parents who: Are unwilling or unable to attend the follow-up sessions. Plan to relocate outside the study area within the study duration, impacting follow-up visits. are with severe illness (e.g., psychiatric disorders, critical postpartum complications etc.) that may hinder participation in the intervention. Preterm neonates with: severe medical conditions on discharge or with other conditions, including III or IV intraventricular haemorrhage, severe sepsis, Birth asphyxia, and major congenital anomalies associated with poor neurodevelopmental outcomes were excluded. diagnosed with severe complications that necessitate prolonged mechanical ventilation or surgical intervention.

Design outcomes

Primary

Measure	Time frame
PRIMARY OUTCOME 1. Infant growth parameters (weight, length and head circumference) PRIMARY OUTCOME 2. Neurodevelopmental outcomes PRIMARY OUTCOME 3. Parent-child interaction quality PRIMARY OUTCOME 4. Parental stress levelTimepoint: Time Point OF PRIMARY OUTCOME 1. Baseline (at NICU admission), 4th month, 8th month and 10th month of corrected Time Point OF PRIMARY OUTCOME 2. Baseline (at NICU admission), 4th month, 8th month and 10th month of corrected a Time Point OF PRIMARY OUTCOME 3. Baseline (at discharge from NICU), 4th month, 8th month and 10th month of corrected age Time Point OF PRIMARY OUTCOME 4. Baseline (at discharge from NICU), 4th month, 8th month and 10th month of corrected age	—

Measure

Time frame

PRIMARY OUTCOME 1. Infant growth parameters (weight, length and head circumference) PRIMARY OUTCOME 2. Neurodevelopmental outcomes PRIMARY OUTCOME 3. Parent-child interaction quality PRIMARY OUTCOME 4. Parental stress levelTimepoint: Time Point OF PRIMARY OUTCOME 1. Baseline (at NICU admission), 4th month, 8th month and 10th month of corrected Time Point OF PRIMARY OUTCOME 2. Baseline (at NICU admission), 4th month, 8th month and 10th month of corrected a Time Point OF PRIMARY OUTCOME 3. Baseline (at discharge from NICU), 4th month, 8th month and 10th month of corrected age Time Point OF PRIMARY OUTCOME 4. Baseline (at discharge from NICU), 4th month, 8th month and 10th month of corrected age

—

Secondary

Measure	Time frame
1.Perceived family support Timepoint: Baseline (at NICU admission), 4th month & 8th month of corrected age;Kangaroo Mother Care practiceTimepoint: Baseline (at discharge), 4th month & 8th month of corrected age;Exclusive breastfeeding practiceTimepoint: Baseline (at discharge), 4th month & 8th month of corrected age	—

Countries

India

Contacts

Public ContactPuspanjali senapati

Manipal Academy of Higher Education (MAHE),manipal

baby.s@manipal.edu9632217067

Outcome results