Ignite Creation Date:
2024-10-26 @ 3:37 PM
Last Modification Date:
2024-10-26 @ 3:37 PM
Study NCT ID:
NCT06545565
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-07-30
Brief Title:
Prevention of Metabolic Acidosis in Preterm Neonates by Replacing Sodium Chloride With Sodium Acetate in Parenteral Nutrition
Sponsor:
None
Organization:
None
Study Overview
Official Title:
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
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PROTECT
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 recommendationsguidelines of sodium acetate in daily PN which are required to preventtreat 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 parentslegal representatives according to local regulations before the initiation of PN Gestational age 33 weeks Included in the study before 72 hours of life
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 recommendationsguidelines of sodium acetate in daily PN which are required to preventtreat 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 parentslegal representatives according to local regulations before the initiation of PN Gestational age 33 weeks Included in the study before 72 hours of life
Detailed Description:
Background Providing optimal nutritional support to extremely preterm and very low birth weight VLBW infants is still very much a challenge as enteral feeding is generally delayed due to the prematurity of gastrointestinal function these infants have poor sucking and swallowing reflexes and there are concerns that a liberal feeding strategy may lead to complications such as feeding intolerance or necrotizing enterocolitis NEC Early nutritional support is primarily delivered through parenteral nutrition PN is essential in the critical management during the neonatal period in these preterm babies
PN provides all the required nutritional needs of preterm including fluid calories and electrolytes Sodium is both an electrolyte and a mineral It helps keep the water the amount of fluid inside and outside the bodys cells and electrolyte balance of the body Sodium is also important in how nerves and muscles work Most of the sodium in the body about 85 is found in blood and lymph fluid Sodium is also provided through PN in two forms The first form is sodium chloride In most parts of the world sodium supplementation in PN has largely been in the form of sodium chloride This is also the standard of care in the neonatal intensive care unit of Aga Khan University Hospital Sodium chloride is added to the PN according to the sodium levels and body fluid balance
The second source of sodium is sodium acetate which is new in Aga Khan University Hospital but internationally used in PN Daily sodium acetate will be added to the PN bag according to the sodium levels acid-base balance and total fluid intake With the addition of sodium acetate neonates have fewer metabolic acidosis complications are more effective in preventing comorbidities and are being used in the NICUs of developed countries
MATERIALS AND METHODS Design This will be a 2-arm open-label phase III randomized controlled trial RCT to compare Sodium acetate and Sodium chloride given daily as the component of parenteral nutrition over during first 28 days of life Investigators will initiate the treatment within the first 72 hours following birth
Setting This study will be conducted in the Neonatal Intensive Care Unit NICU of the Aga Khan University Hospital AKUH which is a 700-bedded not-for-profit tertiary care hospital receiving country-wide referrals
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
Data collection
All relevant maternal and infant demographic dataBaseline characteristics blood investigation results and clinical outcomes will be recorded prospectively The primary outcomes pH and base excess BE will be recorded from pre-PN on the first day of life DOL then 2- 7 DOL and days 10 13 162025 and 28 of life For infants requiring less than 28 days of hospital stay data will be collected till dischargedeath
PN provides all the required nutritional needs of preterm including fluid calories and electrolytes Sodium is both an electrolyte and a mineral It helps keep the water the amount of fluid inside and outside the bodys cells and electrolyte balance of the body Sodium is also important in how nerves and muscles work Most of the sodium in the body about 85 is found in blood and lymph fluid Sodium is also provided through PN in two forms The first form is sodium chloride In most parts of the world sodium supplementation in PN has largely been in the form of sodium chloride This is also the standard of care in the neonatal intensive care unit of Aga Khan University Hospital Sodium chloride is added to the PN according to the sodium levels and body fluid balance
The second source of sodium is sodium acetate which is new in Aga Khan University Hospital but internationally used in PN Daily sodium acetate will be added to the PN bag according to the sodium levels acid-base balance and total fluid intake With the addition of sodium acetate neonates have fewer metabolic acidosis complications are more effective in preventing comorbidities and are being used in the NICUs of developed countries
MATERIALS AND METHODS Design This will be a 2-arm open-label phase III randomized controlled trial RCT to compare Sodium acetate and Sodium chloride given daily as the component of parenteral nutrition over during first 28 days of life Investigators will initiate the treatment within the first 72 hours following birth
Setting This study will be conducted in the Neonatal Intensive Care Unit NICU of the Aga Khan University Hospital AKUH which is a 700-bedded not-for-profit tertiary care hospital receiving country-wide referrals
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
Data collection
All relevant maternal and infant demographic dataBaseline characteristics blood investigation results and clinical outcomes will be recorded prospectively The primary outcomes pH and base excess BE will be recorded from pre-PN on the first day of life DOL then 2- 7 DOL and days 10 13 162025 and 28 of life For infants requiring less than 28 days of hospital stay data will be collected till dischargedeath
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None