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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
SINGLE
Enrollment
900
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.
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.
The University of Alabama at Birmingham
Birmingham, Alabama, United States
RECRUITINGSharp Mary Birch Hospital for Women & Newborns
San Diego, California, United States
RECRUITINGComposite safety score
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
Time frame: from admission to the NICU through hospital discharge (about 4-5 months)
Average axillary temperatures in degrees Celsius (°C)
Time frame: daily from admission to the NICU to day 28
Average daily total fluid intake in milliliters per kilogram per day (mL/kg/d)
Time frame: daily from admission to the NICU to day 28
Average daily total fluid output in milliliters per kilogram per day (mL/kg/d)
Time frame: daily from admission to the NICU to day 28
Average daily weight in grams
Time frame: daily from admission to the NICU to day 28
Average daily serum sodium in milliequivalents per liter per day (mEq/L/d)
Time frame: daily from admission to the NICU to day 28
Highest serum creatinine level in in mg/dL
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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.
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.
Nationwide Children's Hospital - Grant Medical Center
Columbus, Ohio, United States
RECRUITINGNationwide Children's Hospital - Ohio State University Wexner Medical Center
Columbus, Ohio, United States
RECRUITINGChildren's Memorial Hermann Hospital
Houston, Texas, United States
RECRUITINGTexas Children's Hospital
Houston, Texas, United States
RECRUITINGThe Woman's Hospital of Texas
Houston, Texas, United States
RECRUITINGSt. Luke's Baptist Hospital
San Antonio, Texas, United States
RECRUITINGNorth Central Baptist Hospital
San Antonio, Texas, United States
RECRUITINGTime frame: from admission to the NICU to postnatal day 28
Average daily calories administered in kilocalories per kilogram per day (kcal/kg/d)
Time frame: daily from admission to the NICU to day 28
Average daily protein administered in grams per kilogram per day (g/kg/d)
Time frame: daily from admission to the NICU to day 28
Number of participants who were administered insulin
Time frame: from admission to the NICU to postnatal day 28
Number of participants who were administered vasopressor
Time frame: from admission to the NICU to postnatal day 28
Number of unplanned removals of vascular access or breathing tube
Time frame: from admission to the NICU to postnatal day 28
Weight in grams
Time frame: 36 weeks postmenstrual age
Length in centimeters
Time frame: 36 weeks postmenstrual age
Head circumference in centimeters
Time frame: 36 weeks postmenstrual age
Number of participants who survive to hospital discharge
Time frame: from admission to the NICU to discharge (about 4-5 months)
Number of participants with severe (grade III-IV) intraventricular hemorrhage (IVH)
Time frame: from admission to the NICU to discharge (about 4-5 months)
Number of participants with surgical necrotizing enterocolitis (NEC) or focal intestinal perforation (FIP)
Time frame: from admission to the NICU to discharge (about 4-5 months)
Number of participants with grade III bronchopulmonary dysplasia (BPD)
Time frame: from admission to the NICU to discharge (about 4-5 months)
Number of participants with treated retinopathy of prematurity [ROP]
Time frame: from admission to the NICU to discharge (about 4-5 months)
Number of participants with culture-proven late-onset sepsis (LOS)
Time frame: from admission to the NICU to discharge (about 4-5 months)
Number of participants with patent ductus arteriosus (PDA) ligation
Time frame: from admission to the NICU to discharge (about 4-5 months)