Prevention of Metabolic Acidosis in Preterm Neonates by Replacing Sodium Chloride With Sodium Acetate in Parenteral Nutrition - A Randomized Controlled Trial. (PROTECT Trial)

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
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

Eligibility
Participation Requirements
Sex: All
Minimum Age: 1 day
Maximum Age: 3 days
Healthy Volunteers: t
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• Written informed consent obtained by parents/legal representative (according to local regulations) before the initiation of PN.

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

• Gestational age \< 33 weeks

Locations
Other Locations
Pakistan
Aga Khan University Hospital
RECRUITING
Karachi
Contact Information
Primary
Gul Ambreen, PhD
gul.ambreen@aku.edu
+92 3002402035
Backup
Adnan Mirza, MBBS
adnan.mirza@aku.edu
Time Frame
Start Date: 2024-07-10
Estimated Completion Date: 2025-05-10
Participants
Target number of participants: 200
Treatments
Experimental: sodium acetate
Active_comparator: Sodium Chloride
Related Therapeutic Areas
Sponsors
Leads: Aga Khan University Hospital, Pakistan

This content was sourced from clinicaltrials.gov