Extremely Premature Infant
Conditions
Keywords
Humidification Protocol
Brief summary
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.
Interventions
DEVICEHigher (90%) starting RH in the incubator with 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 90% in the incubator, which is weaned to 50% by day 8, and humidity supplementation stopped at day 10.
DEVICELower (70%) starting RH in the incubator with 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.
DEVICEHigher (90%) starting RH in the incubator with 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 90% in the incubator, which is weaned to 50% by day 8, and humidity supplementation stopped at day 28.
DEVICELower (70%) starting RH in the incubator with 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.
Sponsors
The University of Texas Health Science Center, Houston
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
0 Days to 1 Days
Healthy volunteers
No
Inclusion criteria
* Inborn infant of \<25 weeks' gestation admitted to the neonatal intensive care unit (NICU)
Exclusion criteria
* 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 * Infants whose parents request not to participate
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Composite safety score | from admission to the NICU through hospital discharge (about 4-5 months) | 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 |
Secondary
| Measure | Time frame |
|---|---|
| Average axillary temperatures in degrees Celsius (°C) | daily from admission to the NICU to day 28 |
| Average daily total fluid intake in milliliters per kilogram per day (mL/kg/d) | daily from admission to the NICU to day 28 |
| Average daily total fluid output in milliliters per kilogram per day (mL/kg/d) | daily from admission to the NICU to day 28 |
| Average daily weight in grams | daily from admission to the NICU to day 28 |
| Average daily serum sodium in milliequivalents per liter per day (mEq/L/d) | daily from admission to the NICU to day 28 |
| Highest serum creatinine level in in mg/dL | from admission to the NICU to postnatal day 28 |
| Average daily calories administered in kilocalories per kilogram per day (kcal/kg/d) | daily from admission to the NICU to day 28 |
| Average daily protein administered in grams per kilogram per day (g/kg/d) | daily from admission to the NICU to day 28 |
| Number of participants who were administered insulin | from admission to the NICU to postnatal day 28 |
| Number of participants who were administered vasopressor | from admission to the NICU to postnatal day 28 |
| Number of unplanned removals of vascular access or breathing tube | from admission to the NICU to postnatal day 28 |
| Weight in grams | 36 weeks postmenstrual age |
| Length in centimeters | 36 weeks postmenstrual age |
| Head circumference in centimeters | 36 weeks postmenstrual age |
| Number of participants who survive to hospital discharge | from admission to the NICU to discharge (about 4-5 months) |
| Number of participants with severe (grade III-IV) intraventricular hemorrhage (IVH) | from admission to the NICU to discharge (about 4-5 months) |
| Number of participants with surgical necrotizing enterocolitis (NEC) or focal intestinal perforation (FIP) | from admission to the NICU to discharge (about 4-5 months) |
| Number of participants with grade III bronchopulmonary dysplasia (BPD) | from admission to the NICU to discharge (about 4-5 months) |
| Number of participants with treated retinopathy of prematurity [ROP] | from admission to the NICU to discharge (about 4-5 months) |
| Number of participants with culture-proven late-onset sepsis (LOS) | from admission to the NICU to discharge (about 4-5 months) |
| Number of participants with patent ductus arteriosus (PDA) ligation | from admission to the NICU to discharge (about 4-5 months) |
Countries
United States
Contacts
CONTACTMatthew A. Rysavy, MD, PhD
PRINCIPAL_INVESTIGATORMatthew A. Rysavy, MD, PhD
The University of Texas Health Science Center, Houston
Outcome results
None listed