Growth and Feeding Tolerance in Premature Infants
Effect of Early Human Milk Fortification Versus Delayed Fortification on Growth and Feeding Tolerance in Premature Infants: a Randomized Controlled Trial.
1 other identifier
interventional
96
1 country
1
Brief Summary
The main purpose of the study is to evaluate the effect of early human milk fortification versus delayed fortification on growth and feeding tolerance in premature infants.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Feb 2026
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 16, 2026
CompletedStudy Start
First participant enrolled
February 1, 2026
CompletedFirst Posted
Study publicly available on registry
February 13, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
July 1, 2026
February 13, 2026
February 1, 2026
5 months
January 16, 2026
February 6, 2026
Conditions
Outcome Measures
Primary Outcomes (2)
weight gain
● ≥15-20 g/kg/day (or as per predefined growth standards for preterm infants).
2 to 3 months
● Linear growth & head circumference
* Increase in length ≥0.8-1.0 cm/week. * Head circumference growth ≥0.5-0.8 cm/week
2 to 3 months
Secondary Outcomes (2)
● Successful enteral feeding advancement
2 to 3 months
● Absence of intolerance signs
2 to 3 months
Study Arms (1)
delayed initiation of human milk fortification on feeding tolerance
OTHERdelayed initiation of human milk fortification on feeding tolerance
Interventions
early initiation of human milk fortification on feeding tolerance
Eligibility Criteria
You may qualify if:
- Preterm infants born at 28-31+6 weeks' gestation and/or birth weight1000-1500g.
- Exclusively receiving mother's own milk or donor human milk.
- No major congenital anomalies, severe sepsis, or NEC at enrollment.
- Parental/guardian consent
You may not qualify if:
- Extremely pre-term infants
- Infants with congenital gastrointestinal malformations or metabolic disorders.
- Infants with confirmed necrotizing enterocolitis(NEC)Stage II/III or intestinal perforation before enrollment (as these cases indicate significant gastrointestinal morbidity that may interfere with feeding tolerance and growth assessment).
- Infants whose parents decline participation.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
The Children's Hospital and The Institute of Child Health, Multan
Multan Khurd, Punjab Province, 60000, Pakistan
Related Publications (1)
AlizadehTaheri,P.,Sajjadian, N.,AsGharyanFarge,M.,&Shariat,M.(2017).Isearlybreast milk fortification more effective in preterm infants? A clinical trial: Early and late fortification. InJournal of PerinatalMedicine(Vol. 45, Issue8, pp.953-957). Walter de Gruyter GmbH.https://doi.org/10.1515/jpm-2015-0375
BACKGROUND
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER GOV
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- postgraduate resident of peads medicine
Study Record Dates
First Submitted
January 16, 2026
First Posted
February 13, 2026
Study Start
February 1, 2026
Primary Completion (Estimated)
July 1, 2026
Study Completion (Estimated)
July 1, 2026
Last Updated
February 13, 2026
Record last verified: 2026-02
Data Sharing
- IPD Sharing
- Will not share