Growth and Feeding Tolerance in Premature Infants

February 6, 2026 updated by: Dr. Muhammad Asif, Children's Hospital and Institute of Child Health, Multan

Effect of Early Human Milk Fortification Versus Delayed Fortification on Growth and Feeding Tolerance in Premature Infants: a Randomized Controlled Trial.

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

96

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Pakistan
    • Punjab Province
      • Multan Khurd, Punjab Province, Pakistan, 60000
        • The Children's Hospital and The Institute of Child Health, Multan
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: delayed initiation of human milk fortification on feeding tolerance
Dietary supplement: early initiation of human milk fortification on feeding tolerance
early initiation of human milk fortification on feeding tolerance

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
weight gain
Time Frame: 2 to 3 months
● ≥15-20 g/kg/day (or as per predefined growth standards for preterm infants).
2 to 3 months
● Linear growth & head circumference
Time Frame: 2 to 3 months
  • Increase in length ≥0.8-1.0 cm/week.
  • Head circumference growth ≥0.5-0.8 cm/week
2 to 3 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
● Successful enteral feeding advancement
Time Frame: 2 to 3 months
  • Achievement of full enteral feeds (≥150 mL/kg/day) without interruption.
  • No need for feed withholding or reduction due to intolerance
2 to 3 months
● Absence of intolerance signs
Time Frame: 2 to 3 months
  • Gastric residuals <2-3 mL/kg per feed (non-bilious, non-bloody).
  • No emesis, abdominal distension, or NEC (Bell's stage ≥II).
2 to 3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Children's Hospital and Institute of Child Health, Multan

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General 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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

February 1, 2026

Primary Completion (Estimated)

July 1, 2026

Study Completion (Estimated)

July 1, 2026

Study Registration Dates

First Submitted

January 16, 2026

First Submitted That Met QC Criteria

February 6, 2026

First Posted (Actual)

February 13, 2026

Study Record Updates

Last Update Posted (Actual)

February 13, 2026

Last Update Submitted That Met QC Criteria

February 6, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Other Study ID Numbers

  • CHMultan

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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