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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
SINGLE
Enrollment
350
The incubator will be set to an ambient relative humidity (RH) of 70%.
The incubator will be set to an ambient relative humidity (RH) of 90%.
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
Efficacy as assessed by percent of birth weight lost
Time frame: upon admission to the NICU, postnatal week 2
Composite 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 time of admission to the NICU through hospital discharge (about 4-5 months)
Average axillary temperatures in degrees Celsius (°C)
Time frame: 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)
Time frame: 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)
Time frame: from time of admission to the NICU to postnatal day 14
Average daily weight in grams
Time frame: from time of admission to the NICU to postnatal day 14
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
The 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
RECRUITINGAverage daily sodium administered in milliequivalents per kilogram per day (mEq/kg/d)
Time frame: from time of admission to the NICU to postnatal day 14
Average daily serum sodium in milliequivalents per liter per day (mEq/L/d)
Time frame: from time of admission to the NICU to postnatal day 14
Average daily calories administered in kilocalories per kilogram per day (kcal/kg/d)
Time frame: from time of admission to the NICU to postnatal day 14
Average daily protein administered in grams per kilogram per day (g/kg/d)
Time frame: from time of admission to the NICU to postnatal day 14
Number of participants who were administered insulin
Time frame: from time of admission to the NICU to postnatal day 14
Number of participants who were administered vasopressor
Time frame: from time of admission to the NICU to postnatal day 14
Weight
Time frame: 36 weeks postmenstrual age
Length
Time frame: 36 weeks postmenstrual age
Head circumference
Time frame: 36 weeks postmenstrual age
Number of participants who survive to hospital discharge
Time frame: from time of admission to the NICU to discharge (about 4-5 months)
Number of participants with severe (grade III-IV) intraventricular hemorrhage (IVH)
Time frame: 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)
Time frame: from time of admission to the NICU to discharge (about 4-5 months)
Number of participants with grade III bronchopulmonary dysplasia (BPD)
Time frame: from time of admission to the NICU to discharge (about 4-5 months)
Number of participants with treated retinopathy of prematurity [ROP]
Time frame: from time of admission to the NICU to discharge (about 4-5 months)
Number of participants with culture-proven late-onset sepsis (LOS)
Time frame: from time of admission to the NICU to discharge (about 4-5 months)
Number of participants with patent ductus arteriosus (PDA) ligation
Time frame: from time of admission to the NICU to discharge (about 4-5 months)
Number of unplanned removals of vascular access or breathing tube
Time frame: from time of admission to the NICU to postnatal day 14