Clinical trial NCT06484608: Comparison of Isotonic Versus Hypotonic Fluids in Neonates for Maintenance Fluid Therapy After Surgery
Official title: Comparison of Isotonic Versus Hypotonic Fluids in Neonates Receiving Maintenance Fluid Therapy Post-Surgery: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hyponatremia
Hypernatremia
Postoperative Care in Neonates
Edema
Keywords: isotonic saline, hypotonic saline, neonates, maintenance fluid therapy, surgery, hyponatremia
Lead sponsor: Rawalpindi Medical College
Sponsor class: OTHER
First posted: 2024-07-03
Enrollment: 84
Sex: ALL
Minimum age (years): 1
Maximum age (years): 30
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: In this study, participants (neonates post-surgery) are randomly assigned to one of two groups, with each group receiving a different type of intervention (isotonic or hypotonic fluids). The parallel assignment model means that all participants in each group receive the same intervention throughout the study period, and the outcomes of these groups are compared to evaluate the effectiveness and safety of the interventions.
Primary purpose: OTHER

Brief 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.

Detailed description: The primary objective of this clinical trial is to determine the most appropriate type of maintenance fluid (isotonic versus hypotonic) for neonates following surgery. The study enrolled 84 neonates, aged 1-28 days, who were admitted to the neonatal intensive care unit at Holy Family Hospital Rawalpindi from January 2023 to December 2023.

Neonates were randomly assigned into two groups:

Group I: Received isotonic/normal saline with 5% dextrose in 0.9% saline. Group H: Received hypotonic saline with 5% dextrose in 0.45% saline. Blood samples were collected before surgery and 24 hours post-surgery to measure serum sodium levels. The main outcome measures were the incidence of hyponatremia (serum sodium level \<135 mEq/L) and hypernatremia (serum sodium level \>145 mEq/L). Secondary outcomes included other complications such as edema.

The results indicated that:

Hyponatremia occurred in 2 (4.8%) cases in the isotonic group and 11 (26.2%) cases in the hypotonic group.

Hypernatremia was observed in 9 (21.4%) cases in the isotonic group and none in the hypotonic group.

Edema was noted in 1 (2.4%) neonate in the isotonic group and 9 (21.4%) neonates in the hypotonic group.

The study concluded that isotonic saline is more effective in maintaining normal serum sodium levels and reducing the risk of hyponatremia and other complications compared to hypotonic saline in neonates post-surgery. Further research with larger sample sizes and additional electrolyte considerations is recommended to improve outcomes and reduce morbidity and mortality in this population.

Eligibility criteria: 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.

Primary outcomes:
measure: Incidence of Hyponatremia and Hypernatremia
timeFrame: Before surgery (baseline measurement) 24 hours post-surgery
Secondary outcomes:
measure: Incidence of Edema
timeFrame: Before surgery (baseline measurement) 24 hours post-surgery
Other outcomes:
Locations:
city: Rawalpindi
country: Pakistan
facility: Mehak Fatima
state: Punjab
Study officials:
affiliation: RMU
name: Mehak Fatima, MBBS
role: PRINCIPAL_INVESTIGATOR
References: