A Randomized controlled trial comparing restricted vs standard fluid administration in late preterm and term newborn with transient tachypnea of newborn requiring respiratory support
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 210
- 试验地点
- 1
- 主要终点
- Duration of CPAP support in both the groups of babies with TTNB requiring CPAP
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Stratified block randomization
- 盲法
- Not Applicable
入排标准
- 年龄范围
- 0.00 Day(s) 至 1.00 Day(s)（—）
- 性别
- All
入选标准
- •Inborn babies from 34 completed wks to 41 6/7 wks fulfilling the definition of TTNB and requiring CPAP as respiratory support
- •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
- •Parents of eligible babies giving consent for participation.
排除标准
- •Presence of air leak
- •Presence of congenital anomalies
- •Diagnosis of other causes of respiratory distress ( MAS, RDS, suspected sepsis, Surgical causes)
- •Perinatal asphyxia.
结局指标
主要结局
Duration of CPAP support in both the groups of babies with TTNB requiring CPAP
时间窗: 72 hrs
次要结局
- •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)