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Effect of Fortified Human Milk on neuromotor outcomes in preterm infants

Effect of Human milk fortification on neuromotor outcomes in preterm infants: one year hospital based randomised control trial - NIL

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2025/09/094983
Enrollment
70
Registered
2025-09-17
Start date
Unknown
Completion date
Unknown
Last updated
2025-10-13

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: Human Milk Fortification: Intervention group will be supplemented with Fortified Human Milk for at least 21 days and then assessed for neuromotor outcomes after 21 days of mandatory obs

Sponsors

Jawaharlal Nehru Medical College KLE University Belagavi
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Very Low Birth Weight (less than or equal to 1.5kg) or very preterm (28-32 weeks) infants admitted to NICU at study facility less than 24 hours after birth for inborn infants and upto 48 hours for out-born infants. 2. Lives within catchment areas of the facility (50km). 3. Mother intends to stay in catchment area of the study facility for at least 3 months. 4. At randomisation: Infant receiving at least 60 mL per kg in per day of human milk (On Day 10 of life) 5. Willing to participate in the study.

Exclusion criteria

Exclusion criteria: 1. Lives outside the defined catchment area. 2. Congenital abnormalities or acquired conditions that interfere with feeding or placement of Nasogastric/Orogastric tube [cleft lip /palate, toxoplasmosis, other agents, rubella, cytomegalovirus, and herpes (TORCH), Trisomy 21, Congenital cardiac defect, neural tube defect, gastrointestinal (GI) tract anomalies, hydrocephalus, necrotising enterocolitis] 3. Severe birth asphyxia 4. Critically ill (i.e. not on enteral feeds) 5. Unknown date of birth and unknown gestational age

Design outcomes

Primary

MeasureTime frame
To assess the effect of Human milk fortification on neuromotor outcomes in preterm infants using General Movement Assessment (GMA).Timepoint: At the time of discharge from hospital—

Secondary

MeasureTime frame
To assess the effect of risk factors like birth weight, birth length, gestation, gender and weight gain on neuromotor function in the study subjects.Timepoint: The infants will be monitored from the date of admission till the date of discharge.—

Countries

India

Contacts

Public ContactDr S M Dhaded

Jawaharlal Nehru Medical College, KLE University

drdhadedsm@gmail.com9844232586

Outcome results

None listed

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