Humidity in Incubators for Tiny Infants (HumidITI) Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 900
- 试验地点
- 15
- 主要终点
- Composite safety score
研究概览
简要总结
The objective of the study is to compare different supplemental incubator humidification strategies for infants <25 weeks' gestation admitted to the neonatal intensive care unit (NICU). The study aims to compare higher (90%) and lower (70%) starting relative humidity (RH), as well as shorter (10 days) and longer (28 days) duration of humidity supplementation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 0 Days 至 1 Day（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Inborn infant of <25 weeks' gestation admitted to the neonatal intensive care unit (NICU)
排除标准
- •Infants with known congenital skin conditions
- •Outborn infants
- •Infants with unknown gestational age prior to birth
- •Infants with redirection of intensive care prior to study enrollment
- •Infants whose parents request not to participate
研究组 & 干预措施
Incubator ambient relative humidity (RH) of 70%
Infants will be provided usual delivery room care and then placed in an incubator on admission to the NICU, receiving ambient relative humidity (RH) of 70% in the incubator.
干预措施: Incubator ambient relative humidity (RH) of 70% (Device)
Incubator ambient relative humidity (RH) of 90%
Infants will be provided usual delivery room care and then placed in an incubator on admission to the NICU, receiving ambient relative humidity (RH) of 90% in the incubator.
干预措施: Incubator ambient relative humidity (RH) of 90% (Device)
Lower (70%) starting RH in the incubator with humidity supplementation stopped at day 28
Infants will be provided usual delivery room care and then placed in an incubator on admission to the NICU, receiving starting relative humidity (RH) of 70% in the incubator, which is weaned to 50% by day 8, and humidity supplementation stopped at day 28.
干预措施: Lower (70%) starting RH in the incubator with humidity supplementation stopped at day 28 (Device)
Higher (90%) starting RH in the incubator with humidity supplementation stopped at day 10
Infants will be provided usual delivery room care and then placed in an incubator on admission to the NICU, receiving starting relative humidity (RH) of 90% in the incubator, which is weaned to 50% by day 8, and humidity supplementation stopped at day 10.
干预措施: Higher (90%) starting RH in the incubator with humidity supplementation stopped at day 10 (Device)
Lower (70%) starting RH in the incubator with humidity supplementation stopped at day 10
Infants will be provided usual delivery room care and then placed in an incubator on admission to the NICU, receiving starting relative humidity (RH) of 70% in the incubator, which is weaned to 50% by day 8, and humidity supplementation stopped at day 10.
干预措施: Lower (70%) starting RH in the incubator with humidity supplementation stopped at day 10 (Device)
Higher (90%) starting RH in the incubator with humidity supplementation stopped at day 28
Infants will be provided usual delivery room care and then placed in an incubator on admission to the NICU, receiving starting relative humidity (RH) of 90% in the incubator, which is weaned to 50% by day 8, and humidity supplementation stopped at day 28.
干预措施: Higher (90%) starting RH in the incubator with humidity supplementation stopped at day 28 (Device)
结局指标
主要结局
Composite safety score
时间窗: from time of admission to the NICU through hospital discharge (about 4-5 months)
A single composite safety score will be reported (mortality and 6 morbidities will be assessed to determine this score). The composite score ranges from 0 to 7, with a higher score indicating a better outcome, as listed below: * 0 = Infant does not survive * 1 = Infant survives, has all 6 assessed morbidities * 2 = Infant survives, has 5 assessed morbidities * 3 = Infant survives, has 4 assessed morbidities * 4 = Infant survives, has 3 assessed morbidities * 5 = Infant survives, has 2 assessed morbidities * 6 = Infant survives, has 1 assessed morbidities * 7 = Infant survives, has no assessed morbidities Morbidities assessed: * grade III-IV intraventricular hemorrhage (IVH) * surgical necrotizing enterocolitis (NEC) or focal intestinal perforation (FIP) * grade III bronchopulmonary dysplasia (BPD) * treated retinopathy of prematurity (ROP) * culture-proven late-onset sepsis (LOS) * patent ductus arteriosus (PDA) ligation
Efficacy as assessed by percent of birth weight lost
时间窗: upon admission to the NICU, postnatal week 2
Composite safety score
时间窗: from admission to the NICU through hospital discharge (about 4-5 months)
A single composite safety score will be reported (mortality and 6 morbidities will be assessed to determine this score). The composite score ranges from 0 to 7, with a higher score indicating a better outcome, as listed below: * 0 = Infant does not survive * 1 = Infant survives, has all 6 assessed morbidities * 2 = Infant survives, has 5 assessed morbidities * 3 = Infant survives, has 4 assessed morbidities * 4 = Infant survives, has 3 assessed morbidities * 5 = Infant survives, has 2 assessed morbidities * 6 = Infant survives, has 1 assessed morbidities * 7 = Infant survives, has no assessed morbidities Morbidities assessed: * grade III-IV intraventricular hemorrhage (IVH) * surgical necrotizing enterocolitis (NEC) or focal intestinal perforation (FIP) * grade III bronchopulmonary dysplasia (BPD) * treated retinopathy of prematurity (ROP) * culture-proven late-onset sepsis (LOS) * patent ductus arteriosus (PDA) ligation
次要结局
- Average axillary temperatures in degrees Celsius (°C)(from time of admission to the NICU to postnatal day 3)
- Average daily total fluid intake in milliliters per kilogram per day (mL/kg/d)(from time of admission to the NICU to postnatal day 14)
- Average daily total fluid output in milliliters per kilogram per day (mL/kg/d)(from time of admission to the NICU to postnatal day 14)
- Average daily weight in grams(from time of admission to the NICU to postnatal day 14)
- Average daily sodium administered in milliequivalents per kilogram per day (mEq/kg/d)(from time of admission to the NICU to postnatal day 14)
- Average daily serum sodium in milliequivalents per liter per day (mEq/L/d)(from time of admission to the NICU to postnatal day 14)
- Average daily calories administered in kilocalories per kilogram per day (kcal/kg/d)(from time of admission to the NICU to postnatal day 14)
- Average daily protein administered in grams per kilogram per day (g/kg/d)(from time of admission to the NICU to postnatal day 14)
- Number of participants who were administered insulin(from time of admission to the NICU to postnatal day 14)
- Number of participants who were administered vasopressor(from time of admission to the NICU to postnatal day 14)
- Weight(36 weeks postmenstrual age)
- Length(36 weeks postmenstrual age)
- Head circumference(36 weeks postmenstrual age)
- Number of participants who survive to hospital discharge(from time of admission to the NICU to discharge (about 4-5 months))
- Number of participants with severe (grade III-IV) intraventricular hemorrhage (IVH)(from time of admission to the NICU to discharge (about 4-5 months))
- Number of participants with necrotizing enterocolitis (NEC) or focal intestinal perforation (FIP)(from time of admission to the NICU to discharge (about 4-5 months))
- Number of participants with grade III bronchopulmonary dysplasia (BPD)(from time of admission to the NICU to discharge (about 4-5 months))
- Number of participants with treated retinopathy of prematurity [ROP](from time of admission to the NICU to discharge (about 4-5 months))
- Number of participants with culture-proven late-onset sepsis (LOS)(from time of admission to the NICU to discharge (about 4-5 months))
- Number of participants with patent ductus arteriosus (PDA) ligation(from time of admission to the NICU to discharge (about 4-5 months))
- Number of unplanned removals of vascular access or breathing tube(from time of admission to the NICU to postnatal day 14)
- Average axillary temperatures in degrees Celsius (°C)(daily from admission to the NICU to day 28)
- Average daily total fluid intake in milliliters per kilogram per day (mL/kg/d)(daily from admission to the NICU to day 28)
- Average daily total fluid output in milliliters per kilogram per day (mL/kg/d)(daily from admission to the NICU to day 28)
- Average daily weight in grams(daily from admission to the NICU to day 28)
- Average daily serum sodium in milliequivalents per liter per day (mEq/L/d)(daily from admission to the NICU to day 28)
- Highest serum creatinine level in in mg/dL(from admission to the NICU to postnatal day 28)
- Average daily calories administered in kilocalories per kilogram per day (kcal/kg/d)(daily from admission to the NICU to day 28)
- Average daily protein administered in grams per kilogram per day (g/kg/d)(daily from admission to the NICU to day 28)
- Number of participants who were administered insulin(from admission to the NICU to postnatal day 28)
- Number of participants who were administered vasopressor(from admission to the NICU to postnatal day 28)
- Number of unplanned removals of vascular access or breathing tube(from admission to the NICU to postnatal day 28)
- Weight in grams(36 weeks postmenstrual age)
- Length in centimeters(36 weeks postmenstrual age)
- Head circumference in centimeters(36 weeks postmenstrual age)
- Number of participants who survive to hospital discharge(from admission to the NICU to discharge (about 4-5 months))
- Number of participants with severe (grade III-IV) intraventricular hemorrhage (IVH)(from admission to the NICU to discharge (about 4-5 months))
- Number of participants with necrotizing enterocolitis (NEC) or focal intestinal perforation (FIP)(from admission to the NICU to discharge (about 4-5 months))
- Number of participants with grade III bronchopulmonary dysplasia (BPD)(from admission to the NICU to discharge (about 4-5 months))
- Number of participants with treated retinopathy of prematurity [ROP](from admission to the NICU to discharge (about 4-5 months))
- Number of participants with culture-proven late-onset sepsis (LOS)(from admission to the NICU to discharge (about 4-5 months))
- Number of participants with patent ductus arteriosus (PDA) ligation(from admission to the NICU to discharge (about 4-5 months))
- Number of participants with surgical necrotizing enterocolitis (NEC) or focal intestinal perforation (FIP)(from admission to the NICU to discharge (about 4-5 months))
研究者
Matthew Rysavy
Associate Professor
The University of Texas Health Science Center, Houston