Health TrialsbyHealthPanel

Growth and Feeding Tolerance in Premature Infants

ConditionsFeeding ToleranceGrowth
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age28-31
SponsorChildren's Hospital and Institute of Child Health, Multan

About this 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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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.

Trial design

Design model

Single group

Treatments tested in this trial

  • early initiation of human milk fortification on feeding tolerance

    Dietary supplement

    early initiation of human milk fortification on feeding tolerance

Treatment groups

96 Participants
are divided into 1 treatment group
Group A: delayed initiation of human milk fortification on feeding toleranceOther 1 intervention

Trial outcomes

Primary outcomes

1

weight gain

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

Time frame
2 to 3 months
2

● Linear growth & head circumference

* Increase in length ≥0.8-1.0 cm/week. * Head circumference growth ≥0.5-0.8 cm/week

Time frame
2 to 3 months

Secondary outcomes

1

● Successful enteral feeding advancement

* Achievement of full enteral feeds (≥150 mL/kg/day) without interruption. * No need for feed withholding or reduction due to intolerance

Time frame
2 to 3 months
2

● Absence of intolerance signs

* Gastric residuals \<2-3 mL/kg per feed (non-bilious, non-bloody). * No emesis, abdominal distension, or NEC (Bell's stage ≥II).

Time frame
2 to 3 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Children's Hospital and Institute of Child Health, Multan

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: