Application of human milk into Nose for brain protection in premature babies

Efficacy and Safety of Intranasal Application of Human Milk for Neuroprotection in Preterm Infants: A Randomized Controlled Tiral

Status

Recruiting

Phases

Phase 2Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2023/01/049335

Enrollment

140

Registered

2023-01-31

Start date

Unknown

Completion date

Unknown

Last updated

2023-02-06

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

Conditions

Health Condition 1: P919- Disturbance of cerebral status ofnewborn, unspecified

Interventions

Intervention1: Intranasal application of human milk: Fresh human milk (0.2 ml) will be instilled intranasally into each nostril every 6 hours, using a one-ml syringe, starting within 48 hours of life.

Eligibility

Inclusion criteria

Inclusion criteria: 1. Preterm neonates of less than 34 weeks of gestational age

Exclusion criteria

Exclusion criteria: 1. Chromosomal anomalies 2. Major congenital malformations 3. Microcephaly 4. Dysmorphic features 5. Critically sick newborns unlikely to survive 6. Suspected intrauterine infection 7. Failure to obtain consent

Design outcomes

Primary

Measure	Time frame
Brain MRI findingsTimepoint: at term equivalent age of 40 plus minus 2 weeks of postmenstrual age	—

Secondary

Measure	Time frame
Brain MRI findingsTimepoint: at corrected age of 6 plus minus 1 month;Intracranial hemorrhage as detected by cranial ultrasoundTimepoint: on days 5-7 of age, and term equivalent age or early if discharged early;Late onset sepsisTimepoint: during birth hospitalization;Length of hospital stayTimepoint: at the time of discharge;MortalityTimepoint: during birth hospitalization;Mothers response and acceptance to intranasal application of human milkTimepoint: during hospitalization;Neurodevelopmental assesmentTimepoint: at corrected age of 6 plus minus 1 month, 1 year plus minus 1 month;Safety of intranasal application of human milk as evidenced by fall in oxygen saturation of more than 10 percent from baseline, increase in oxygen requirement of more than 10 percent, heart rate below 100 per minute, apnea or choking episode during application, change in color of body, restlessness, escalation of respiratory supportTimepoint: during hospitalization	—

Measure

Time frame

Brain MRI findingsTimepoint: at corrected age of 6 plus minus 1 month;Intracranial hemorrhage as detected by cranial ultrasoundTimepoint: on days 5-7 of age, and term equivalent age or early if discharged early;Late onset sepsisTimepoint: during birth hospitalization;Length of hospital stayTimepoint: at the time of discharge;MortalityTimepoint: during birth hospitalization;Mothers response and acceptance to intranasal application of human milkTimepoint: during hospitalization;Neurodevelopmental assesmentTimepoint: at corrected age of 6 plus minus 1 month, 1 year plus minus 1 month;Safety of intranasal application of human milk as evidenced by fall in oxygen saturation of more than 10 percent from baseline, increase in oxygen requirement of more than 10 percent, heart rate below 100 per minute, apnea or choking episode during application, change in color of body, restlessness, escalation of respiratory supportTimepoint: during hospitalization

—

Countries

India

Contacts

Public ContactAditi Agarwal

Banaras Hindu University

ashokkumar_bhu@hotmail.com09415300370

Outcome results

None listed

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