Not yet recruiting NCT07409038
Growth and Feeding Tolerance in Premature Infants
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: early initiation of human milk fortification on feeding tolerance.
- Who it may be relevant to
- Registry conditions: Feeding Tolerance, Growth. Basic parameters: 28 Weeks — 31 Weeks · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Pakistan
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Effect of Early Human Milk Fortification Versus Delayed Fortification on Growth and Feeding Tolerance in Premature Infants: a Randomized Controlled Trial.
Overview
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.
Interventions
- Dietary supplement early initiation of human milk fortification on feeding tolerance
early initiation of human milk fortification on feeding tolerance
Primary outcome measures
- weight gain [Time frame: 2 to 3 months]
- ● Linear growth & head circumference [Time frame: 2 to 3 months]
Secondary outcome measures (2)
- ● Successful enteral feeding advancement [Time frame: 2 to 3 months]
- ● Absence of intolerance signs [Time frame: 2 to 3 months]
Eligibility criteria
Inclusion criteria
- 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
Exclusion criteria
- 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Supportive care
Study locations
Pakistan · 1 center
- The Children's Hospital and The Institute of Child Health, Multan — Multan Khurd
Publications
- 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
Identifiers
NCT: NCT07409038 · CHMultan