Prevention of Metabolic Acidosis in Preterm Neonates by Replacing Sodium Chloride With Sodium Acetate in Parenteral Nutrition
NCT Number: NCT06545565
Acronym: PROTECT
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE3
Conditions: Metabolic Acidosis|Neonatal Disease|Neonatal Complication
Interventions: DRUG: sodium acetate group will receive sodium acetate in the neonatal PN.|DRUG: sodium chloride group will receive sodium chloride in the neonatal PN.
Sponsor: Aga Khan University Hospital, Pakistan
Sex: ALL
Age: CHILD
Enrollment: 200
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: OTHER
Start Date: 2024-07-10
Completion Date: 2025-05-10
Locations: Aga Khan University Hospital, Karachi, Sindh, 74800, Pakistan

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

Primary Outcome Measures: 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 Outcome Measures: 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, number of days participant receive ventilatory support, 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), daily weight gain or loss of the participants in grams (g), 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, total number of days participants required inotropic support, 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, participant survival or death, up to 4 weeks