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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Incubator ambient relative humidity (RH) of 70% | Active Comparator | Infants will be provided usual delivery room care and then placed in an incubator on admission to the NICU, receiving ambient relative humidity (RH) of 70% in the incubator. |
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| Incubator ambient relative humidity (RH) of 90% | Experimental | Infants will be provided usual delivery room care and then placed in an incubator on admission to the NICU, receiving ambient relative humidity (RH) of 90% in the incubator. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Incubator ambient relative humidity (RH) of 70% | Device | The incubator will be set to an ambient relative humidity (RH) of 70%. |
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| Measure | Description | Time Frame |
|---|---|---|
| Efficacy as assessed by percent of birth weight lost | 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:
Morbidities assessed:
| from time of admission to the NICU through hospital discharge (about 4-5 months) |
| Measure | Description | Time Frame |
|---|---|---|
| Average axillary temperatures in degrees Celsius (°C) | 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) | from time of admission to the NICU to postnatal day 14 |
| Measure | Description | Time Frame |
|---|---|---|
| Average total pre-discharge costs | Total pre-discharge costs (assessed from the health system perspective) encompass facility costs and professional service costs. | from time of admission to the NICU to discharge (about 4-5 months) |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Matthew A. Rysavy, MD, PhD | Contact | 713-500-5651 | Matthew.A.Rysavy@uth.tmc.edu |
| Name | Affiliation | Role |
|---|---|---|
| Matthew A. Rysavy, MD, PhD | The University of Texas Health Science Center, Houston | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Nationwide Children's Hospital - Grant Medical Center | Recruiting | Columbus | Ohio | 43205 | United States |
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| Incubator ambient relative humidity (RH) of 90% | Device | The incubator will be set to an ambient relative humidity (RH) of 90%. |
|
| Average daily total fluid output in milliliters per kilogram per day (mL/kg/d) | from time of admission to the NICU to postnatal day 14 |
| Average daily weight in grams | from time of admission to the NICU to postnatal day 14 |
| Average daily sodium administered in milliequivalents per kilogram per day (mEq/kg/d) | from time of admission to the NICU to postnatal day 14 |
| Average daily serum sodium in milliequivalents per liter per day (mEq/L/d) | from time of admission to the NICU to postnatal day 14 |
| Average daily calories administered in kilocalories per kilogram per day (kcal/kg/d) | from time of admission to the NICU to postnatal day 14 |
| Average daily protein administered in grams per kilogram per day (g/kg/d) | from time of admission to the NICU to postnatal day 14 |
| Number of participants who were administered insulin | from time of admission to the NICU to postnatal day 14 |
| Number of participants who were administered vasopressor | from time of admission to the NICU to postnatal day 14 |
| Weight | 36 weeks postmenstrual age |
| Length | 36 weeks postmenstrual age |
| Head circumference | 36 weeks postmenstrual age |
| Number of participants who survive to hospital discharge | from time of admission to the NICU to discharge (about 4-5 months) |
| Number of participants with severe (grade III-IV) intraventricular hemorrhage (IVH) | 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) | from time of admission to the NICU to discharge (about 4-5 months) |
| Number of participants with grade III bronchopulmonary dysplasia (BPD) | from time of admission to the NICU to discharge (about 4-5 months) |
| Number of participants with treated retinopathy of prematurity [ROP] | from time of admission to the NICU to discharge (about 4-5 months) |
| Number of participants with culture-proven late-onset sepsis (LOS) | from time of admission to the NICU to discharge (about 4-5 months) |
| Number of participants with patent ductus arteriosus (PDA) ligation | from time of admission to the NICU to discharge (about 4-5 months) |
| Number of unplanned removals of vascular access or breathing tube | from time of admission to the NICU to postnatal day 14 |
| Nationwide Children's Hospital - Ohio State University Wexner Medical Center | Recruiting | Columbus | Ohio | 43210 | United States |
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| Children's Memorial Hermann Hospital | Recruiting | Houston | Texas | 77030 | United States |
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| The Woman's Hospital of Texas | Recruiting | Houston | Texas | 77054 | United States |
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| St. Luke's Baptist Hospital | Recruiting | San Antonio | Texas | 78229 | United States |
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| North Central Baptist Hospital | Recruiting | San Antonio | Texas | 78258 | United States |
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