Skip to content

Beneficial effect of oral application of colostrum or mothers own milk in preterm babies.

To evaluate the beneficial effect of oral application of colostrum or mothers own milk in preterm baby A randomised controlled trial - NIL

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2024/10/076044
Enrollment
128
Registered
2024-10-29
Start date
Unknown
Completion date
Unknown
Last updated
2024-11-11

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

Conditions

Health Condition 1: E649- Sequelae of unspecified nutritional deficiency

Interventions

Intervention1: Mothers own milk/ colostrum: Route- Oropharyngeal Dose- 0.2 ml ofMothers own milk/ colostrum Duration: Till 32 weeks Frequency: Every 2 hours for 48 hours, then every 3 hours Control In

Sponsors

Datta Meghe Institute of Higher Education and Research,
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Sick babies with less than 32 weeks of gestation requiring CPAP or ventilation who is not receiving feed directly. 2) Mother plans to pump and provide milk for babies admitted in NICU. 3) NICU admissions less than 24 hrs. of life and inborn babies 4) Ability to begins protocol within 96 hours of life.

Exclusion criteria

Exclusion criteria: Babies having 1. birth asphyxia (cord ph/arterial ph less than7) 2. Presence of significant congenital anomalies 4. Parents not giving consent

Design outcomes

Primary

MeasureTime frame
The serum IgA level values in two groups The incidence of Ventilatory associated pneumoniaTimepoint: Oral application of milk - 24 hours Serum IgA blood values at 7 days of life Septic Screening at 7-10 days Discharge or death at the time of discharge 4-6 weeks

Secondary

MeasureTime frame
Total days of hospital stay The incidence of septicaemia and necrotising enterocolitis Outcome in form of death or dischargeTimepoint: Subject enrolment at 24 hours of life Application of milk at 48 hours of life Estimation of serum IgA level at 7 and 14 days of life Recording of occurrence of septicaemia and necrotising enterocolitis at any of time Collection of Mortality data throughout and at the time of discharge

Countries

India

Contacts

Public ContactDr Amar Taksande

Datta Meghe Institute of Higher Education and Research,Sawangi Meghe.

amar.taksande@gmail.com09822369233

Outcome results

None listed

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