A study comparing liberal versus restricted fluid administration in newborn with respiratory distress after birth.

Phase 1

Completed

Conditions: Transient tachypnea of newborn,

Registration Number: CTRI/2019/01/017125

Lead Sponsor: Institute of Post Graduate Medical Education and Research Department of Neonatology

Brief Summary: **BACKGROUND:** Transienttachypnea of the newborn(TTNB) is the most common respiratory morbidity in latepreterm and term babiesand is pathophysiologically related to delayed lung fluid clearance after birth. Mimickinglow physiological fluid intakein the initial period of life may accelerate the recovery from TTNB. In a randomized controlled trial, we comparedthe roles of restricted versus standard fluid management in babies with TTNBrequiring respiratory support.

**METHODS:** This parallel group,non-blinded,stratified randomized controlled trial was conducted in a level III neonatalunit of eastern India. Late preterm and term babies with TTNB requiringcontinuous positive airway pressure (CPAP) wererandomly allocated to standard and restricted fluid arms for the first 72 hours(hrs). Primary outcome was CPAP duration.

**RESULTS:** Intotal, 100 babieswere enrolled in this study with 50 babies in each arm. CPAP duration was significantly less in the restricted arm (48[42, 54] hrsvs 54[48,72] hrs, *p* = 0.002). However, no difference was observed in theincidence of CPAP failurebetween the two arms. In the subgroupanalysis, the benefitof reduced CPAP durationpersisted in late pretermbut not in term infants.However, the effect was not significant in the late preterm babiesexposed to antenatal steroid.

**CONCLUSION:** This trial demonstrated the safety and effectiveness of restrictive fluid strategy in reducing CPAP duration in late preterm and term babieswith TTNB. Late preterm babies, especially those not exposed to antenatalsteroid were the most benefitted bythis strategy.

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: All

Target Recruitment: 210

Inclusion Criteria

Inborn babies from 34 completed wks to 41 6/7 wks fulfilling the definition of TTNB and requiring CPAP as respiratory support 2.
Outborn babies presenting within 6 hrs of life of gestational age 34 completed wks to 41 6/7 wks fulfilling the definition of TTNB and requiring CPAP as respiratory support 3.
Parents of eligible babies giving consent for participation.

Exclusion Criteria

Presence of air leak 2.
Presence of congenital anomalies 3.
Diagnosis of other causes of respiratory distress ( MAS, RDS, suspected sepsis, Surgical causes) 4.
Perinatal asphyxia.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Duration of CPAP support in both the groups of babies with TTNB requiring CPAP	72 hrs

Secondary Outcome Measures

Name	Time	Method
â€¢Incidence of CPAP failure in newborn with TTNB requiring CPAP in standard fluid management and restricted fluid manageent group.	72 hrs
Incidence of neonatal morbidities ( Hyperbilirubinemia, Hypoglycemia, dehydration )in both the groups of babies with TTNB requiring CPAP	72 hrs
Duration of NICU stay in both the groups of babies with TTNB requiring CPAP	7 days

Trial Locations

Locations (1): Institute of Post Graduate Medical Education and Research, kolkata
🇮🇳
Kolkata, WEST BENGAL, India
Institute of Post Graduate Medical Education and Research, kolkata
🇮🇳Kolkata, WEST BENGAL, India
Somnath pal
Principal investigator
9903457386
somnathpal1983@gmail.com