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Lactation Excellence and Partnership (LEAP) Programme: Enhancing Breast Milk Nutrition, Nutritional Markers, and Growth in Preterm Babies

EFFECTIVENESS OF LACTATION EXCELLENCE AND PARTNERSHIP(LEAP)PROGRAMME ON BREASTMILK MACRONUTRIENTS,NUTRITIONAL MARKERS AND GROWTH OUTCOMES OF PRETERM INFANTS - NILL

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2025/06/088753
Enrollment
220
Registered
2025-06-12
Start date
Unknown
Completion date
Unknown
Last updated
2026-04-27

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

Conditions

Health Condition 1: P929- Feeding problem of newborn, unspecified

Interventions

Intervention1: LEAP-LACTATION EXCELLENCE AND PARTNERSHIP PROGRAMME: LEAP Group CONSIST OF SIX SESSION 1 Early Milk Expression 2 Feeding Options Challenges 3 Starting Breastfeeding 4 Home Visit 1 Wee

Sponsors

Department of Health Research (DHR)
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Preterm Infants and their family residing within a radius of 50 km from the study setting during the postnatal period 2. Family who understand Tamil or/and English 3. Singleton Infants born with a gestation of 27-33+6 weeks 4. Baby and mother delivered or admitted at the study setting within 24 hrs of birth 5. Willing for follow-up home visits

Exclusion criteria

Exclusion criteria: 1. Women with any contraindication for breastfeeding such as mothers with a breast infection and Retrovirus positive 2. Baby with significant congenital defects and medical complications namely Oesophageal 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
Macronutrient composition: Protein, Fat, Carbohydrates, and Energy content in MOM Biochemical markers: Calcium, Phosphorus, Albumin, Alkaline Phosphatase, BUN, Sodium,caclium and phosphorus Volume of Mother s Own Milk (MOM) intake Timepoint: Collect 1 ml of Mother s Own Milk from each feed over a 24-hour period on days 7, 14 and 28. Blood tests are conducted as a part of preterm investigation after 3 weeks of life till 34 weeks as routine clinical care Total volume of MOM intake will be measured on the following days- day 7, day 14, day 21 and day 28 until the day of direct breastfeeding

Secondary

MeasureTime frame
Infant growth parameters (weight, length, head circumference, growth velocity) Timepoint: corrected age 3 months

Countries

India

Contacts

Public ContactMs.DEVIKA.E

SRI RAMACHANDRA FACULTY OF NURSING,SRIRAMACHANDRA INSTITUTE OF HIGHER EDUCATION AND RESEARCH(DU)

sjnalini@sriramachandra.edu.in9444668095

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: May 1, 2026