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Prevention of Metabolic Acidosis in Preterm Neonates by Replacing Sodium Chloride With Sodium Acetate in Parenteral Nutrition

NCT06545565 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 200

Last updated 2024-08-09

No results posted yet for this study

Summary

The goal of this clinical trial is to learn if the addition of sodium acetate in neonatal PN works to prevent and treat metabolic acidosis and associated comorbidities in preterm neonates. It will also teach about the optimal doses of sodium acetate in PN. The main questions it aims to answer are:

Is the incidence of metabolic acidosis reduced in preterm neonates who received daily Sodium acetate in PN therapy (treatment) during the initial weeks of life compared with individuals who received sodium chloride in PN (standard)? Is the rate of neonatal comorbidities reduced in preterm neonates who received daily Sodium acetate in PN therapy (treatment) during the initial weeks of life compared with individuals who received sodium chloride in PN (standard)? What are the optimal neonatal dosing recommendations/guidelines of sodium acetate in daily PN, which are required to prevent/treat metabolic acidosis in the early life of preterm neonates? Researchers will compare Sodium acetate in PN therapy to sodium chloride in PN to see if Sodium acetate works to prevent and treat metabolic acidosis and associated comorbidities.

Included Participants:

All the neonates were admitted to the NICU of AKUH and received PN during 28 days of their lives.

Participants will receive sodium acetate or sodium chloride Written informed consent was obtained by parents/legal representatives (according to local regulations) before the initiation of PN. Gestational age \< 33 weeks Included in the study before 72 hours of life

Conditions

  • Metabolic Acidosis
  • Neonatal Disease
  • Neonatal Complication

Interventions

DRUG

sodium acetate group will receive sodium acetate in the neonatal PN.

This group will receive sterile sodium acetate daily in the neonatal PN for the duration the patient will receive parenteral nutrition, a maximum of 28 days of life.

DRUG

sodium chloride group will receive sodium chloride in the neonatal PN.

This group will receive sterile sodium chloride daily in the neonatal PN for the duration the patient will receive parenteral nutrition, a maximum of 28 days of life.

Sponsors & Collaborators

  • Aga Khan University Hospital, Pakistan

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
1 Day
Max Age
3 Days
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-07-10
Primary Completion
2025-05-10
Completion
2025-05-10

Countries

  • Pakistan

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 NCT06545565 on ClinicalTrials.gov