Clinical trial NCT06399861: Humidity in Incubators for Tiny Infants
Official title: Humidity in Incubators for Tiny Infants (HumidITI) Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Extremely Premature Infant
Keywords: Humidification Protocol
Lead sponsor: The University of Texas Health Science Center, Houston
Sponsor class: OTHER
First posted: 2024-05-06
Enrollment: 350
Sex: ALL
Minimum age (years): 0
Maximum age (years): 1
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.


Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* Infants with known congenital skin conditions
* Outborn infants
* Infants with unknown gestational age prior to birth

Primary outcomes:
measure: Efficacy as assessed by percent of birth weight lost
timeFrame: upon admission to the NICU, postnatal week 2
measure: Composite safety score
timeFrame: from time of admission to the NICU through hospital discharge (about 4-5 months)
Secondary outcomes:
measure: Average axillary temperatures in degrees Celsius (°C)
timeFrame: from time of admission to the NICU to postnatal day 3
measure: Average daily total fluid intake in milliliters per kilogram per day (mL/kg/d)
timeFrame: from time of admission to the NICU to postnatal day 14
measure: Average daily total fluid output in milliliters per kilogram per day (mL/kg/d)
timeFrame: from time of admission to the NICU to postnatal day 14
measure: Average daily weight in grams
timeFrame: from time of admission to the NICU to postnatal day 14
measure: Average daily sodium administered in milliequivalents per kilogram per day (mEq/kg/d)
timeFrame: from time of admission to the NICU to postnatal day 14
measure: Average daily serum sodium in milliequivalents per liter per day (mEq/L/d)
timeFrame: from time of admission to the NICU to postnatal day 14
measure: Average daily calories administered in kilocalories per kilogram per day (kcal/kg/d)
timeFrame: from time of admission to the NICU to postnatal day 14
measure: Average daily protein administered in grams per kilogram per day (g/kg/d)
timeFrame: from time of admission to the NICU to postnatal day 14
measure: Number of participants who were administered insulin
timeFrame: from time of admission to the NICU to postnatal day 14
measure: Number of participants who were administered vasopressor
timeFrame: from time of admission to the NICU to postnatal day 14
measure: Weight
timeFrame: 36 weeks postmenstrual age
measure: Length
timeFrame: 36 weeks postmenstrual age
measure: Head circumference
timeFrame: 36 weeks postmenstrual age
measure: Number of participants who survive to hospital discharge
timeFrame: from time of admission to the NICU to discharge (about 4-5 months)
measure: Number of participants with severe (grade III-IV) intraventricular hemorrhage (IVH)
timeFrame: from time of admission to the NICU to discharge (about 4-5 months)
measure: Number of participants with necrotizing enterocolitis (NEC) or focal intestinal perforation (FIP)
timeFrame: from time of admission to the NICU to discharge (about 4-5 months)
measure: Number of participants with grade III bronchopulmonary dysplasia (BPD)
timeFrame: from time of admission to the NICU to discharge (about 4-5 months)
measure: Number of participants with treated retinopathy of prematurity [ROP]
timeFrame: from time of admission to the NICU to discharge (about 4-5 months)
measure: Number of participants with culture-proven late-onset sepsis (LOS)
timeFrame: from time of admission to the NICU to discharge (about 4-5 months)
measure: Number of participants with patent ductus arteriosus (PDA) ligation
timeFrame: from time of admission to the NICU to discharge (about 4-5 months)
measure: Number of unplanned removals of vascular access or breathing tube
timeFrame: from time of admission to the NICU to postnatal day 14
Other outcomes:
measure: Average total pre-discharge costs
timeFrame: from time of admission to the NICU to discharge (about 4-5 months)
Locations:
city: Columbus
country: United States
facility: Nationwide Children's Hospital - Grant Medical Center
state: Ohio
city: Columbus
country: United States
facility: Nationwide Children's Hospital - Ohio State University Wexner Medical Center
state: Ohio
city: Houston
country: United States
facility: Children's Memorial Hermann Hospital
state: Texas
city: Houston
country: United States
facility: The Woman's Hospital of Texas
state: Texas
city: San Antonio
country: United States
facility: St. Luke's Baptist Hospital
state: Texas
city: San Antonio
country: United States
facility: North Central Baptist Hospital
state: Texas
Study officials:
affiliation: The University of Texas Health Science Center, Houston
name: Matthew A. Rysavy, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: