Comparison of Isotonic Versus Hypotonic Fluids in Neonates for Maintenance Fluid Therapy After Su… (NCT06484608) | Clinical Trial Compass
CompletedNot Applicable
Comparison of Isotonic Versus Hypotonic Fluids in Neonates for Maintenance Fluid Therapy After Surgery
Pakistan84 participantsStarted 2023-01-01
Plain-language summary
The goal of this clinical trial is to determine if isotonic or hypotonic fluids are more effective in maintaining serum sodium levels in neonates undergoing maintenance fluid therapy post-surgery. The main questions it aims to answer are:
Does isotonic fluid therapy reduce the risk of hyponatremia compared to hypotonic fluid therapy? Does hypotonic fluid therapy lead to fewer cases of hypernatremia compared to isotonic fluid therapy? Researchers will compare neonates receiving isotonic fluids (Group I: isotonic/normal saline with 5% dextrose in 0.9% saline) to those receiving hypotonic fluids (Group H: hypotonic saline with 5% dextrose in 0.45% saline) to see if there are significant differences in serum sodium levels and associated complications.
Participants will:
Be randomly assigned to receive either isotonic or hypotonic fluids. Have blood samples taken before and after surgery to assess serum sodium levels.
Be monitored for 24 hours post-surgery to observe any complications such as hyponatremia, hypernatremia, or edema.
This study enrolled 84 neonates admitted to the neonatal intensive care unit following surgery, and data analysis was conducted using SPSS software version 25.0.
Who can participate
Age range
1 Day – 30 Days
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Neonates aged 1-28 days. Admitted to the neonatal intensive care unit (NICU) at Holy Family Hospital Rawalpindi.
Scheduled for surgery requiring maintenance fluid therapy postoperatively. Parental or guardian consent obtained.
Exclusion Criteria:
* Neonates with pre-existing electrolyte imbalances or metabolic disorders. Neonates with congenital heart disease or renal impairment. Neonates on diuretics or other medications affecting fluid balance. Neonates with a history of intrauterine growth restriction (IUGR). Neonates with major congenital anomalies. Lack of parental or guardian consent.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial compared isotonic versus hypotonic fluids in newborns after surgery to see which caused fewer sodium imbalances — has this study's data been published yet, and if so, what did it find about the safest fluid choice for my baby?
2Since the trial specifically tracked both hyponatremia and hypernatremia as risks of post-surgical fluid therapy in neonates, how does my baby's current sodium level and overall condition factor into which type of IV fluid you would choose for them?
3The trial also looked at edema as a concern in newborns receiving maintenance fluids after surgery — is fluid-related swelling something we need to watch for in my baby's specific situation, and how would you monitor for it?
4Now that this trial is completed, does the evidence from it change or reinforce the fluid management approach you were already planning for my baby, or is the standard of care in this area still unsettled?
5Are there other completed or ongoing studies on post-surgical fluid therapy in newborns that you think are more directly relevant to my baby's diagnosis, and how do you weigh all of that evidence when making your decision?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Incidence of Hyponatremia and Hypernatremia
Timeframe: Before surgery (baseline measurement) 24 hours post-surgery