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 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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Inborn infant of <25 weeks' gestation admitted to the NICU

Disqualifiers

Infants with known congenital skin conditions

Outborn infants

Infants with unknown gestational age prior to birth

Trial design

Design model

Parallel

Treatments tested in this trial

Incubator ambient relative humidity (RH) of 70%
Device
The incubator will be set to an ambient relative humidity (RH) of 70%.
Incubator ambient relative humidity (RH) of 90%
Device
The incubator will be set to an ambient relative humidity (RH) of 90%.

Treatment groups

350 Participants

are divided into 2 treatment groups

Group A: Incubator ambient relative humidity (RH) of 70%Active comparator 1 intervention

Group B: Incubator ambient relative humidity (RH) of 90%Experimental treatment 1 intervention

Trial outcomes

Primary outcomes

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)

Secondary outcomes

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

Other outcomes

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

Click on the lead sponsor to view all of their trials.

The University of Texas Health Science Center, Houston

Lead sponsor

Source ClinicalTrials.gov

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