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ACTIVE NOT RECRUITING
NCT07350135
NA

Sodium Supplementation and Growth in Premature Neonates

Sponsor: Ain Shams University

View on ClinicalTrials.gov

Summary

Primary aim: to assess the impact of late (≥7 days postnatal) sodium supplementation of premature neonates with birth weight less than 2500 gm on their postnatal short-term catch-up growth. Secondary aim: to find out the effect of this sodium supplementation on fractional excretion of sodium, hemodynamics and prematurity-related short-term neonatal outcomes including morbidities and morality.

Official title: Impact of Sodium Supplementation on Postnatal Growth of Premature Neonates: a Randomised Controlled Clinical Trial

Key Details

Gender

All

Age Range

7 Days - 28 Days

Study Type

INTERVENTIONAL

Enrollment

74

Start Date

2025-11-06

Completion Date

2028-12-30

Last Updated

2026-01-20

Healthy Volunteers

Yes

Interventions

DRUG

Sodium supplementation guided by serum sodium and fraction sodium in urine

The Study population will be stratified according to gender and gestational age and randomly assigned into 2 groups: * Group A: will receive sodium supplementation with a moderate dose (4 mEq/kg/day) above basic maintenance requirements starting from 7 days to 28 days after birth. Sodium will be supplemented in the form of hypertonic saline provided either parenteral (added to maintenance intravenous fluid) or enteral, if oral intake exceeds 100 ml/kg/day (divided and added to feds every 6 hours) \[9\] (withhold supplementation if the serum sodium reaches 150 mmol/L, or development of vomiting or diarrhea with oral supplementation). * Group B: control group will receive basic maintenance requirements of the sodium supplementation (3mEq/kg/day).

Locations (1)

Eldemerdash Hospital

Cairo, Egypt