Humidity in Incubators for Tiny Infants
- Conditions
- Extremely Premature Infant
- Interventions
- Device: Incubator ambient relative humidity (RH) of 90%Device: Incubator ambient relative humidity (RH) of 70%
- Registration Number
- NCT06399861
- Brief Summary
The objective of the study is to assess 2 different initial incubator humidification protocols for infants \<25 weeks' gestation admitted to the neonatal intensive care unit (NICU). The hypothesis is that a higher starting humidity decreases dehydration and results in no difference in survival or morbidity. Higher (90%) and lower (70%) starting humidity will be compared.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 350
- Inborn infant of <25 weeks' gestation admitted to the NICU
- Infants with known congenital skin conditions
- Outborn infants
- Infants with unknown gestational age prior to birth
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Incubator ambient relative humidity (RH) of 90% 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. Incubator ambient relative humidity (RH) of 70% 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.
- Primary Outcome Measures
Name Time Method Composite safety score 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) ligationEfficacy as assessed by percent of birth weight lost upon admission to the NICU, postnatal week 2
- Secondary Outcome Measures
Name Time Method 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
Trial Locations
- Locations (6)
Nationwide Children's Hospital - Grant Medical Center
🇺🇸Columbus, Ohio, United States
Nationwide Children's Hospital - Ohio State University Wexner Medical Center
🇺🇸Columbus, Ohio, United States
Children's Memorial Hermann Hospital
🇺🇸Houston, Texas, United States
The Woman's Hospital of Texas
🇺🇸Houston, Texas, United States
St. Luke's Baptist Hospital
🇺🇸San Antonio, Texas, United States
North Central Baptist Hospital
🇺🇸San Antonio, Texas, United States