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Family Integrated Lactation Management for Preterm Babies

Effectiveness of Family Integrated Lactation Management on breastmilk feeding outcomes among preterm babies

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2022/10/046204
Enrollment
220
Registered
2022-10-06
Start date
Unknown
Completion date
Unknown
Last updated
2024-05-27

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

Conditions

Health Condition 1: P073- Preterm [premature] newborn [other]

Interventions

Intervention1: Family Integrated Lactation management(FILM): Family Integrated Lactation Management (FILM) service is a lactation management intervention program involving parental skill training, par

Sponsors

Founder Chancellor Shri NPVRamasamy Udayar Research FellowshipSRIHER
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Preterm baby and family residing within a radius of 50 km from the study setting during the postnatal period. 2. Family who understand Tamil. 3. Singleton babies born with gestation of 27-34 weeks. 4. Babies admitted to NICU within 24 hrs of birth 5. Willing to have a home visit by the lactation counselor within one to two weeks post-discharge

Exclusion criteria

Exclusion criteria: 1.Mothers with a abnormal breast conditions and infection, covid positive and Retrovirus positive 2.Baby with significant congenital defects and medical complications namely Esophageal atresia, tracheoesophageal fistula, cleft lip, cleft palate, congenital heart disease, congenital diaphragmatic hernia, a structural defect that affects breastfeeding and survival rate 3.Baby with galactosemia

Design outcomes

Primary

MeasureTime frame
i. Determine the effectiveness of FILM on Breastmilk Feeding Rate in terms of early establishment of Mother’s Own Milk (MOM) feeding and exclusive MOM feeding rate among preterm babies. ii. Evaluate the effectiveness of FILM on infant feeding outcomes in terms of coming to volume, dose and exposure of MOM, feeding milestones and infant health outcomes Timepoint: at 14th postnatal day, on the day of discharge, 40 weeks, 46 weeks and 52 weeks postmenstrual age.

Secondary

MeasureTime frame
Determine the effectiveness of FILM on Family’s breastmilk feeding outcomes in terms of Breastfeeding problems, Maternal experience, Maternal self - efficacy, and Paternal self-efficacyTimepoint: on the day of discharge, 40 weeks and 46 weeks postmenstrual age.

Countries

India

Contacts

Public ContactUrmila U

Sri Ramachandra Institute of Higher Education and Research (DU)

sjnalini@sriramachandra.edu.in9791171684

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026