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Sodium Supplementation and Growth in Premature Neonates

NCT07350135 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 74

Last updated 2026-01-20

No results posted yet for this study

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.

Conditions

  • Sodium Supplementation and Growth in Premature Neonates

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).

Sponsors & Collaborators

  • Ain Shams University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
7 Days
Max Age
28 Days
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2025-11-06
Primary Completion
2028-11-06
Completion
2028-12-30

Countries

  • Egypt

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07350135 on ClinicalTrials.gov