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

NCT06545565 | Recruiting Phase 3

• 1 other identifier: 2024-6523-29448
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

metabolic acidosis; sodium acetate; neonates; Parenteral Nutrition

Outcome Measures

Primary Outcomes (1)

• metabolic acidosis

  Severe metabolic acidosis, in critically ill neonates, is defined as a persistent low Blood pH \< 7.26 and it also involves a primary decrease in serum bicarbonate (HCO3-) concentration \<16 mEq/L\]

  Blood-ph and serum-bicarbonate concentration will be recorded from pre-PN on the first day of life (DOL), then 2-7 DOL, and days 10,13,16,20,25&28 of life. For infants requiring <28 days of hospital stay until discharge/death.

Secondary Outcomes (5)

• Development of Comorbid conditions (Bronchopulmonary dysplasia (BPD), patent ductus arteriosus (PDA), Intraventricular hemorrhage (IVH), Retinopathy of prematurity (ROP), necrotizing enterocolitis (NEC), Sepsis and jaundice ).

  From the date of randomization until the date of first documented comorbid condition, assessed up to 28 days of life or date of death from any cause, whichever came first.

• Duration of ventilation

  Participants will be assessed from the date of randomization up to 28 days of life or date of death from any cause, whichever came first.

• Weight change (gain/loss)

  Participants will be assessed for daily weight from the date of randomization up to 28 days of life or date of death from any cause, whichever came first.

• use of inotropes, plasma volume expanders and sodium bicarbonate therapy

  Participants will be assessed for the use of inotropes, plasma volume expanders and sodium bicarbonate therapy from the date of randomization up to 28 days of life or date of death from any cause, whichever came first.

• survival

  up to 4 weeks

Study Arms (2)

sodium acetate

EXPERIMENTAL

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

Sodium Chloride

ACTIVE COMPARATOR

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

Interventions

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

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.

Also known as: Sodium Acetate

sodium acetate

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

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.

Also known as: sodium Chloride

Sodium Chloride

Eligibility Criteria

• Age: 1 Day - 3 Days
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• Infants with an inborn error of metabolism
• Genetic or congenital condition that affects neurodevelopment or requires multiple surgeries (e.g., congenital viral infection, hydrops, complex congenital heart disease, severe dysmorphic features, etc.)
• Severe metabolic alkalosis, in critically ill neonates, is defined as a persistent elevation of the serum pH above 7.45 and it also involves a primary increase in serum bicarbonate (HCO3-) concentration \> 25mEq/L.
• Severe Hypernatremia, in critically ill neonates, is defined as persistently high serum sodium levels \> 150 mmol/L
• Severe liver failure and syndromic infants with multiple congenital abnormalities and severe perinatal asphyxia

Sponsors & Collaborators

• Aga Khan University Hospital, Pakistan: lead

Study Sites (1)

Aga Khan University Hospital

Karachi, Sindh, 74800, Pakistan

RECRUITING

MeSH Terms

Conditions

Acidosis; Infant, Newborn, Diseases; Hyperphagia

Interventions

Sodium Acetate; Sodium Chloride

Condition Hierarchy (Ancestors)

Acid-Base Imbalance; Metabolic Diseases; Nutritional and Metabolic Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Acetic Acid; Acetates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Central Study Contacts

Gul Ambreen, PhD

CONTACT

+92 3002402035; gul.ambreen@aku.edu

Adnan Mirza, MBBS

CONTACT

adnan.mirza@aku.edu

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Assistant Professor

Model Details: Infants who will meet the inclusion criteria and whose parents will consent to participate will be randomized to one of the two intervention groups (So-A, or the standard So-C) prior to the preparation and commencement of PN. Randomization will be performed by pharmacists at the Sterile Preparation/Parenteral Unit of AKU hospital upon enrolment of each case. The randomization process will be performed according to a computer-generated list. For multiple births, each infant will be individually randomized. The interventional group: This group will receive sodium acetate in the neonatal PN. Control Group: The control group will receive sodium chloride in the neonatal PN. Intervention of the study: Use of sodium acetate in neonatal PN.

Study Record Dates

• First Submitted: July 30, 2024
• First Posted: August 9, 2024
• Study Start: July 10, 2024
• Primary Completion: May 10, 2025
• Study Completion: May 10, 2025
• Last Updated: August 9, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)