Skip to content

Does earlier enrichment of human breast milk with nutrients leads to earlier weight gain in premature babies.

Does early fortification of human milk decrease time to regain birth weight as compared to late fortification among preterm infants ââ?¬â?? A Randomized Controlled Trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2020/07/026744
Enrollment
120
Registered
2020-07-23
Start date
Unknown
Completion date
Unknown
Last updated
2022-10-17

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: Early fortification group (intervention group) ââ?¬â?? participants getting fortification of human milk with Human milk fortifier (HMF) when feed reaches @ 30 ml/kg/day .: This study w

Sponsors

JIPMER
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Intramural preterm infants of less than or equal to 32 weeks of gestational age admitted in JIPMER NICU during study period.

Exclusion criteria

Exclusion criteria: 1. Any newborn infant with major congenital malformations or chromosomal anomaly 2. Major gastrointestinal surgical conditions like gastroschisis, congenital diaphragmatic hernia, anorectal malformation, intestinal atresia 3. Hemodynamically unstable neonates

Design outcomes

Primary

MeasureTime frame
Time required in days to regain birth weightTimepoint: Daily weight monitoring untill baby regains birth weight and then weekly monitoring of weight untill 4 weeks of postnatal age.

Secondary

MeasureTime frame
1. Mean of weight gain velocity(gm/kg/day) 2. Mean of linear growth (cm/week) 3. Mean of head circumference growth(cm/week).Timepoint: Every week till 4 weeks of Postnatal age.;4.Mean duration of hospital stay in days. 5.Proportion of infants with feed intolerance during hospital stay. 6.Proportion of infants with necrotizing enterocolitis stage 2 or stage 3. 7.Days required to reach full feeds greater than or equal to 150ml/kg/day. Timepoint: Till the baby is discharged from hospital.

Countries

India

Contacts

Public ContactDr Adhisivam B

JIPMER

drgaurav.amu@gmail.com8375875195

Outcome results

None listed

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