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NCT Number: NCT07409038

Growth and Feeding Tolerance in Premature Infants

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.

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Key information

Conditions

Feeding Tolerance Growth

Age range

28 week–31 week

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The Children's Hospital and The Institute of Child Health, Multan

Multan Khurd, Punjab Province, 60000, Pakistan

Location contact

The Children's Hospital and The Institute of Child Health, Mul Medical Superintendent

CONTACT

[email protected]

(061) 9201431

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

early initiation of human milk fortification on feeding tolerance

Dietary Supplement

early initiation of human milk fortification on feeding tolerance

Primary outcomes

  1. weight gain

    Time frame: 2 to 3 months

    ● ≥15-20 g/kg/day (or as per predefined growth standards for preterm infants).

  2. ● 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

Secondary outcomes

  1. ● 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. ● 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).

Study contacts

Contact information is provided by the study sponsor or research team.

Dr Muhammad Asif Doctor, MBBS

CONTACT

[email protected]

00923143329514

Sponsors and collaborators

Lead sponsor

Children's Hospital and Institute of Child Health, Multan

Other Gov

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Feb 13, 2026
Registry last updated
Feb 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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