Skip to content

ROLE OF ORAL APPLICATION OF COLOSTRUM IN IMPROVEMENT OF HEALTH IN PRETERM INFANTS

A RANDOMIZED CONTROLLED TRIAL OF ORAL APPLICATION OF COLOSTRUM TO IMPROVE HEALTH OUTCOMES IN PRETERM INFANTS

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2017/03/008031
Enrollment
128
Registered
2017-03-07
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

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

Conditions

Health Condition 1: null- Preterm infants born between 26 - 30 wks period of gestation, Morbidity and mortality associated with prematurity

Interventions

Intervention1: Colostrum: Colostrum obtained from mother in first few days of life Control Intervention1: Sterile water: Commercially available distilled sterile water

Sponsors

SUDEEP K C
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Inborn infants with gestation of 26 to 30weeks admitted under neonatology unit

Exclusion criteria

Exclusion criteria: 1. Parents not willing to give consent 2. Babies born with major life threatening congenital malformations 3.Babies born with severe birth asphyxia 4. If breast milk feeding is contraindicated 5. Triplets and higher birth orders 6. Infants already enrolled in any other research/ study that can influence our study outcomes 4.5.vii Colostrum is unavailable at the time of enrolment.

Design outcomes

Primary

MeasureTime frame
Adverse health outcome Adverse health outcome will be a composite of occurrence of any one of the following : (a) death during hospital stay, (b) culture positive or probable sepsis, (c) necrotizing enterocolitis stage 2 , (d) bronchopulmonary dysplasia , (e) intraventricular hemorrhage grade 2, (f) retinopathy of prematurity needing treatment Timepoint: The outcome will be assessed at time of death , discharge or transfer to another hospital.

Secondary

MeasureTime frame
Bronchopulmonary dysplasiaTimepoint: Till death, discharge or transfer to another hospital;Days on antibioticsTimepoint: Till death, discharge or transfer to another hospital;Definite sepsis Probable sepsisTimepoint: Till death, discharge or transfer to another hospital;Intraventricular HemorrhageTimepoint: Till death, discharge or transfer to another hospital;MortalityTimepoint: Prior to discharge from hospital;Necrotising EnterocolitisTimepoint: Till death , discharge or transfer to another hospital;Retinopathy of prematurityTimepoint: Till death, discharge or transfer to another hospital;Time to full feedTimepoint: Till death, discharge or transfer to another hospital

Countries

India

Contacts

Public ContactDr Praveen Kumar

POST GRADUATE INSTITUTE OF MEDICAL EDUCATION AND RESEARCH (PGIMER)

drpkumarpgi@gmail.com7087008302

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 19, 2026