RESTRICTED VERSUS STANDARD FLUID MANAGEMENT IN TRANSIENT TACHYPNEA OF THE NEWBORN: A RANDOMIZED CONTROLLED TRIAL IN AN INDIAN NICU

Abstract

Background: Transient tachypnea of the newborn (TTN) is a common self‐limiting respiratory disorder of term and late‐preterm infants caused by delayed clearance of fetal lung fluid. Standard management is supportive, but limited evidence exists on optimal fluid therapy. Fluid restriction may enhance alveolar fluid absorption and improve respiratory outcomes. This study compares a restricted versus standard maintenance fluid regimen on clinical outcomes in neonates with TTN. Materials and Methods: We conducted a single-center, parallel-arm randomized controlled trial (July 2024–Dec 2025) in neonates (gestational age 34–42 weeks) diagnosed with TTN by clinical and radiographic criteria. Neonates were randomized (n=82, 41 per arm) to receive either a restricted fluid (60ml/kg for preterm neonates and 40ml/kg for term neonates) or standard fluids (80ml/kg in preterm and 60ml/kg in term neonates). Primary outcome was type of oxygen support, duration of oxygen support and length of hospital stay and secondary outcome time to enteral feeding, and incidence of complications (electrolyte disturbances, weight loss). Data were analyzed on an intention‐to‐treat basis using Student’s t-test or χ² test as appropriate; effect sizes (mean differences, 95% confidence intervals) and p‐values are reported, with p<0.05 considered significant. Results: Baseline demographics (gestational age, birthweight, sex, scores) were similar between groups (Table 1). Restricted‐fluid infants required significantly shorter respiratory support (mean 26.4±8.2 vs 34.7±10.1 hours; mean difference −8.3 h, 95% CI −13.5 to −3.1; p=0.002) and had shorter hospitalization (4.20±1.21 vs 5.13±1.34 days; MD −0.93 d, 95% CI −1.46 to −0.40; p=0.003). They also achieved full enteral feeds earlier (mean 2.88±0.87 vs 3.88±0.75 days; MD −1.00 d, 95% CI −1.37 to −0.63; p<0.001) and first feeding earlier (1.76±0.58 vs 2.17±0.59 days; MD −0.41 d, 95% CI −0.65 to −0.17; p=0.002). Subgroup analyses (term vs late preterm) showed similar trends favoring restricted fluids, though interaction was not statistically significant (Table 3). There were no significant differences in adverse events; for example, hypernatremia and hypoglycemia rates were comparable. Figure 1 illustrates key outcome comparisons. Conclusion: In this RCT of neonates with TTN, a restricted fluid regimen was safe and associated with shorter respiratory support and hospital stay compared to standard fluids. These findings align with prior trials and suggest potential benefit of fluid restriction in TTN. However, given limitations (sample size, single-center) and very low-certainty evidence overall, larger multicenter studies are needed.