Humidity in Incubators for Tiny Infants
ConditionExtremely Premature Infant
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age0-1
SponsorThe University of Texas Health Science Center, Houston
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Inborn infant of <25 weeks' gestation admitted to the neonatal intensive care unit (NICU)
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
Higher (90%) starting RH in the incubator with humidity supplementation stopped at day 10
DeviceInfants 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.
Lower (70%) starting RH in the incubator with humidity supplementation stopped at day 10
DeviceInfants 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.
Higher (90%) starting RH in the incubator with humidity supplementation stopped at day 28
DeviceInfants 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.
Lower (70%) starting RH in the incubator with humidity supplementation stopped at day 28
DeviceInfants 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.
Treatment groups
900 Participants
are divided into 4 treatment groupsGroup A: Higher (90%) starting RH in the incubator with humidity supplementation stopped at day 10Active comparator 1 intervention
Group B: Lower (70%) starting RH in the incubator with humidity supplementation stopped at day 10Active comparator 1 intervention
Group C: Higher (90%) starting RH in the incubator with humidity supplementation stopped at day 28Active comparator 1 intervention
Group D: Lower (70%) starting RH in the incubator with humidity supplementation stopped at day 28Active comparator 1 intervention
Trial outcomes
Primary outcomes
1
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 admission to the NICU through hospital discharge (about 4-5 months)Secondary outcomes
1
Average axillary temperatures in degrees Celsius (°C)
Time frame
daily from admission to the NICU to day 282
Average daily total fluid intake in milliliters per kilogram per day (mL/kg/d)
Time frame
daily from admission to the NICU to day 283
Average daily total fluid output in milliliters per kilogram per day (mL/kg/d)
Time frame
daily from admission to the NICU to day 284
Average daily weight in grams
Time frame
daily from admission to the NICU to day 28Other outcomes
1
Average total pre-discharge costs
Total pre-discharge costs (assessed from the health system perspective) encompass facility costs and professional service costs.
Time frame
from time of admission to the NICU to discharge (about 4-5 months)Sponsors and contacts
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Source ClinicalTrials.gov