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.

Status

Not yet recruiting

Phases

Unknown

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT07409038

Enrollment

Registered

2026-02-13

Start date

2026-02-01

Completion date

2026-07-01

Last updated

2026-02-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Feeding Tolerance, Growth

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.

Interventions

DIETARY_SUPPLEMENTearly initiation of human milk fortification on feeding tolerance

early initiation of human milk fortification on feeding tolerance

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

SUPPORTIVE_CARE

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

28 Weeks to 31 Weeks

Healthy volunteers

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.

Design outcomes

Primary

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

Secondary

Measure	Time frame	Description
● Successful enteral feeding advancement	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
● Absence of intolerance signs	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).

Countries

Pakistan

Contacts

CONTACTDr Muhammad Asif Doctor, MBBS

drasif18june@gmail.com00923143329514

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 14, 2026