Extremely Premature InfantHumidITINCT06399861
Humidity in Incubators for Tiny Infants
A study testing Higher (90%) starting RH in the incubator with humidity supplementation stopped at day 10, Lower (70%) starting RH in the incubator with humidity supplementation stopped at day 10 and Higher (90%) starting RH in the incubator with humidity supplementation stopped at day 28 in people with Extremely Premature Infant, run by The University of Texas Health Science Center, Houston at 9 sites in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 0 days to 1 day
- Conditions the study is for
- Extremely Premature Infant
- What is being tested?
- Higher (90%) starting RH in the incubator with humidity supplementation stopped at day 10, Lower (70%) starting RH in the incubator with humidity supplementation stopped at day 10 and Higher (90%) starting RH in the incubator with humidity supplementation stopped at day 28
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 900 participants
- Where
- 9 sitesUnited States
- Study dates
- 25 Jun 2024to 1 Jun 2030
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 0 days to 1 day
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Inborn infant of <25 weeks' gestation admitted to the neonatal intensive care unit (NICU)
Who cannot join
- 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
Trial locations and contacts
9 sites in 1 country. Contact the study team or a site near you to ask about taking part.
9 sites in 1 country
United States9 sites, 9 recruiting
- Recruiting
The University of Alabama at Birmingham
Birmingham, Alabama, 35294
Colm Travers, MD, cptravers@uabmc.edu
Colm Travers, MD
- Recruiting
Nationwide Children's Hospital - Grant Medical Center
Columbus, Ohio, 43205
Carl Backes, MD, 614-722-2000, Carl.Backes@nationwidechildrens.org
Carl Backes, MD
- Recruiting
Nationwide Children's Hospital - Ohio State University Wexner Medical Center
Columbus, Ohio, 43210
Carl Backes, MD, 614-293-8000, Carl.Backes@nationwidechildrens.org
Carl Backes, MD
- Recruiting
Children's Memorial Hermann Hospital
Houston, Texas, 77030
Matthew A. Rysavy, MD, PhD, 713-500-5651, Matthew.A.Rysavy@uth.tmc.edu
Matthew Rysavy, MD
- Recruiting
Texas Children's Hospital
Houston, Texas, 77030
Shweta Parmekar, MD, Shweta.Parmekar@bcm.edu
Shweta Parmekar, MD
- Recruiting
The Woman's Hospital of Texas
Houston, Texas, 77054
Kaashif Ahmad, MD, kahmad@uh.edu
Kaashif Ahmad, MD, Mac
- Recruiting
St. Luke's Baptist Hospital
San Antonio, Texas, 78229
Christine Aune, MD, 210-297-5000, Christine_Aune@mednax.com
Christine Aune, MD
- Recruiting
North Central Baptist Hospital
San Antonio, Texas, 78258
Brent Reyburn, MD, 210-297-4000, brent.reyburn@pediatrix.com
Brent Reyburn, MD
- Recruiting
Sharp Mary Birch Hospital for Women & Newborns
San Diego, California, 92123
Rachelle Sey, PhD, CNS, RNC-NIC, Rachelle.Sey@sharp.com
Katherine Coughlin, MD, katherine.coughlin@sharp.com
About this study
Official title: Humidity in Incubators for Tiny Infants (HumidITI) 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.
- Conditions
- Extremely Premature Infant
- Being tested
- Higher (90%) starting RH in the incubator with humidity supplementation stopped at day 10, Lower (70%) starting RH in the incubator with humidity supplementation stopped at day 10, Higher (90%) starting RH in the incubator with humidity supplementation stopped at day 28, Lower (70%) starting RH in the incubator with humidity supplementation stopped at day 28
- Keywords
- Humidification Protocol
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Higher (90%) starting RH in the incubator with humidity supplementation stopped at day 10Device
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.
Lower (70%) starting RH in the incubator with humidity supplementation stopped at day 10Device
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.
Higher (90%) starting RH in the incubator with humidity supplementation stopped at day 28Device
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.
Lower (70%) starting RH in the incubator with humidity supplementation stopped at day 28Device
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.
| Study group | Role | What they receive |
|---|---|---|
| Higher (90%) starting RH in the incubator with humidity supplementation stopped at day 10 | Active comparator | 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. Receives: Device: Higher (90%) starting RH in the incubator with humidity supplementation stopped at day 10 |
| Lower (70%) starting RH in the incubator with humidity supplementation stopped at day 10 | Active comparator | 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. Receives: Device: Lower (70%) starting RH in the incubator with humidity supplementation stopped at day 10 |
| Higher (90%) starting RH in the incubator with humidity supplementation stopped at day 28 | Active comparator | 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. Receives: Device: Higher (90%) starting RH in the incubator with humidity supplementation stopped at day 28 |
| Lower (70%) starting RH in the incubator with humidity supplementation stopped at day 28 | Active comparator | 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. Receives: Device: Lower (70%) starting RH in the incubator with humidity supplementation stopped at day 28 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: from admission to the NICU through hospital discharge (about 4-5 months)
Secondary outcomes (21)
Average axillary temperatures in degrees Celsius (°C)
Measured: daily from admission to the NICU to day 28
Average daily total fluid intake in milliliters per kilogram per day (mL/kg/d)
Measured: daily from admission to the NICU to day 28
Average daily total fluid output in milliliters per kilogram per day (mL/kg/d)
Measured: daily from admission to the NICU to day 28
Average daily weight in grams
Measured: daily from admission to the NICU to day 28
Average daily serum sodium in milliequivalents per liter per day (mEq/L/d)
Measured: daily from admission to the NICU to day 28
Highest serum creatinine level in in mg/dL
Measured: from admission to the NICU to postnatal day 28
Average daily calories administered in kilocalories per kilogram per day (kcal/kg/d)
Measured: daily from admission to the NICU to day 28
Average daily protein administered in grams per kilogram per day (g/kg/d)
Measured: daily from admission to the NICU to day 28
Number of participants who were administered insulin
Measured: from admission to the NICU to postnatal day 28
Number of participants who were administered vasopressor
Measured: from admission to the NICU to postnatal day 28
Number of unplanned removals of vascular access or breathing tube
Measured: from admission to the NICU to postnatal day 28
Weight in grams
Measured: 36 weeks postmenstrual age
Length in centimeters
Measured: 36 weeks postmenstrual age
Head circumference in centimeters
Measured: 36 weeks postmenstrual age
Number of participants who survive to hospital discharge
Measured: from admission to the NICU to discharge (about 4-5 months)
Number of participants with severe (grade III-IV) intraventricular hemorrhage (IVH)
Measured: from admission to the NICU to discharge (about 4-5 months)
Number of participants with surgical necrotizing enterocolitis (NEC) or focal intestinal perforation (FIP)
Measured: from admission to the NICU to discharge (about 4-5 months)
Number of participants with grade III bronchopulmonary dysplasia (BPD)
Measured: from admission to the NICU to discharge (about 4-5 months)
Number of participants with treated retinopathy of prematurity [ROP]
Measured: from admission to the NICU to discharge (about 4-5 months)
Number of participants with culture-proven late-onset sepsis (LOS)
Measured: from admission to the NICU to discharge (about 4-5 months)
Number of participants with patent ductus arteriosus (PDA) ligation
Measured: from admission to the NICU to discharge (about 4-5 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2024
- Study start25 Jun 2024
- Primary completion15 Jan 2030 (estimated)
- Study completion1 Jun 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Extremely Premature InfantStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 900 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The University of Texas Health Science Center, Houston
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Matthew Rysavy, The University of Texas Health Science Center, Houston
- Investigators
- Matthew A. Rysavy, MD, PhD, Principal investigator, The University of Texas Health Science Center, Houston
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06399861
- Sponsor's protocol ID
- HSC-MS-24-0206
- Acronym
- HumidITI
- Status last verified
- Sep 2026
- First submitted
- 26 Apr 2024
- Last updated
- 11 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Humidity in Incubators for Tiny Infants (HumidITI) Trial
- ClinicalTrials.gov ID
- NCT06399861
- Acronym / sponsor ID
- HumidITI / HSC-MS-24-0206
- Conditions
- Extremely Premature Infant
- Keywords
- Humidification Protocol
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 900 participants (estimated)
- Lead sponsor
- The University of Texas Health Science Center, HoustonUniversity, hospital or other
- Study start
- 25 Jun 2024 (actual)
- Primary completion
- 15 Jan 2030 (estimated)
- Study completion
- 1 Jun 2030 (estimated)
- First posted
- 6 May 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Higher (90%) starting RH in the incubator with humidity supplementation stopped at day 10 | Active comparator | Device: Higher (90%) starting RH in the incubator with humidity supplementation stopped at day 10Infants 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 | Active comparator | Device: Lower (70%) starting RH in the incubator with humidity supplementation stopped at day 10Infants 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 | Active comparator | Device: Higher (90%) starting RH in the incubator with humidity supplementation stopped at day 28Infants 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 | Active comparator | Device: Lower (70%) starting RH in the incubator with humidity supplementation stopped at day 28Infants 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. |
Who may qualify
- Ages
- 0 days to 1 day
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Inborn infant of <25 weeks' gestation admitted to the neonatal intensive care unit (NICU)
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Higher (90%) starting RH in the incubator with humidity supplementation stopped at day 10Infants 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. | Device | Higher (90%) starting RH in the incubator with humidity supplementation stopped at day 10 |
| Lower (70%) starting RH in the incubator with humidity supplementation stopped at day 10Infants 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. | Device | Lower (70%) starting RH in the incubator with humidity supplementation stopped at day 10 |
| Higher (90%) starting RH in the incubator with humidity supplementation stopped at day 28Infants 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. | Device | Higher (90%) starting RH in the incubator with humidity supplementation stopped at day 28 |
| Lower (70%) starting RH in the incubator with humidity supplementation stopped at day 28Infants 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. | Device | Lower (70%) starting RH in the incubator with humidity supplementation stopped at day 28 |
Primary outcome
Composite safety score
Time frame: 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
21 secondary outcomes
Average axillary temperatures in degrees Celsius (°C)
Time frame: daily from admission to the NICU to day 28
Average daily total fluid intake in milliliters per kilogram per day (mL/kg/d)
Time frame: daily from admission to the NICU to day 28
Average daily total fluid output in milliliters per kilogram per day (mL/kg/d)
Time frame: daily from admission to the NICU to day 28
Average daily weight in grams
Time frame: daily from admission to the NICU to day 28
Average daily serum sodium in milliequivalents per liter per day (mEq/L/d)
Time frame: daily from admission to the NICU to day 28
Highest serum creatinine level in in mg/dL
Time frame: from admission to the NICU to postnatal day 28
Average daily calories administered in kilocalories per kilogram per day (kcal/kg/d)
Time frame: daily from admission to the NICU to day 28
Average daily protein administered in grams per kilogram per day (g/kg/d)
Time frame: daily from admission to the NICU to day 28
Number of participants who were administered insulin
Time frame: from admission to the NICU to postnatal day 28
Number of participants who were administered vasopressor
Time frame: from admission to the NICU to postnatal day 28
Number of unplanned removals of vascular access or breathing tube
Time frame: from admission to the NICU to postnatal day 28
Weight in grams
Time frame: 36 weeks postmenstrual age
Length in centimeters
Time frame: 36 weeks postmenstrual age
Head circumference in centimeters
Time frame: 36 weeks postmenstrual age
Number of participants who survive to hospital discharge
Time frame: from admission to the NICU to discharge (about 4-5 months)
Number of participants with severe (grade III-IV) intraventricular hemorrhage (IVH)
Time frame: from admission to the NICU to discharge (about 4-5 months)
Number of participants with surgical necrotizing enterocolitis (NEC) or focal intestinal perforation (FIP)
Time frame: from admission to the NICU to discharge (about 4-5 months)
Number of participants with grade III bronchopulmonary dysplasia (BPD)
Time frame: from admission to the NICU to discharge (about 4-5 months)
Number of participants with treated retinopathy of prematurity [ROP]
Time frame: from admission to the NICU to discharge (about 4-5 months)
Number of participants with culture-proven late-onset sepsis (LOS)
Time frame: from admission to the NICU to discharge (about 4-5 months)
Number of participants with patent ductus arteriosus (PDA) ligation
Time frame: from admission to the NICU to discharge (about 4-5 months)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Sep 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Matthew A. Rysavy, MD, PhD principal investigator
The University of Texas Health Science Center, Houston
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Higher (90%) starting RH in the incubator with humidity supplementation stopped at day 10, Lower (70%) starting RH in the incubator with humidity supplementation stopped at day 10 and Higher (90%) starting RH in the incubator with humidity supplementation stopped at day 28 in people with Extremely Premature Infant, run by The University of Texas Health Science Center, Houston at 9 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 11 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Matthew A. Rysavy, MD, PhD (713-500-5651, Matthew.A.Rysavy@uth.tmc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Composite safety score (time frame: from admission to the NICU through hospital discharge (about 4-5 months)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Sep 2026.