Humidity Levels in Incubators for Preemies

(HumidITI Trial)

Recruiting at 7 trial locations

Overseen By Matthew A. Rysavy, MD, PhD

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: The University of Texas Health Science Center, Houston

Disqualifiers: Congenital skin conditions, Outborn, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 4-5 months

350 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests two different humidity levels in incubators for very premature babies born before 25 weeks. Researchers aim to determine if starting with higher humidity in the incubator reduces dehydration without impacting the babies' survival or health. Infants in the study will be placed in incubators with either 90% or 70% humidity. Babies born before 25 weeks and admitted to the NICU are eligible, provided they do not have certain skin conditions or unknown gestational ages. As an unphased trial, this study offers a unique opportunity to contribute to important research that could enhance care for very premature infants.

Will I have to stop taking my current medications?

The trial information does not specify whether participants need to stop taking their current medications.

What prior data suggests that these incubator humidification protocols are safe for preemies?

A previous study found that humidity in incubators is crucial for newborns, especially those born very early. Higher humidity aids skin development and can prevent dehydration. However, research has also shown that very high humidity, such as 90%, might increase infection risk in these babies, with a reported 26% increase in infections. Conversely, lower humidity, like 70%, can cause more water loss from the body, potentially leading to dehydration and high sodium levels in the blood. Each humidity level has its pros and cons, so understanding these factors can help determine the best approach for each baby. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores how different humidity levels in incubators might benefit premature infants in the NICU. Current standard care involves maintaining certain temperature and humidity levels, but this trial specifically compares 70% and 90% relative humidity to see which is more effective at improving outcomes for these vulnerable babies. The higher humidity level could potentially enhance skin hydration and reduce evaporative water loss, which might lead to better thermoregulation and overall health. By pinpointing the optimal humidity level, this trial hopes to refine neonatal care practices and improve survival and development in preemies.

What evidence suggests that these incubator humidity settings are effective for preemies?

This trial will compare two humidity levels in incubators for premature babies: 70% and 90% ambient relative humidity (RH). Research has shown that more humid incubators can help prevent water loss in premature babies. One study found that very premature babies in 90% humidity lost less water than those in 70% humidity. However, another study found that higher humidity might increase the risk of infections. While 90% humidity can help keep babies hydrated, it might also raise the risk of infection. Finding the right balance is crucial to determine the best humidity level for these babies. ^{2 3 5 6 7}

Who Is on the Research Team?

Matthew Rysavy, MD, PhD

Principal Investigator

The University of Texas Health Science Center, Houston

Are You a Good Fit for This Trial?

This trial is for newborns born at less than 25 weeks' gestation and admitted to the NICU. It's not open to babies with congenital skin conditions, those born outside of the study hospital, or if their exact age before birth isn't known.

Inclusion Criteria

My baby was born before 25 weeks and is in the NICU.

Exclusion Criteria

Outborn infants

Infants with unknown gestational age prior to birth

My infant has a diagnosed skin condition from birth.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Infants are placed in an incubator with either 90% or 70% ambient relative humidity upon admission to the NICU

4-5 months

Continuous monitoring in NICU

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Incubator ambient relative humidity (RH) of 70%
• Incubator ambient relative humidity (RH) of 90%

Trial Overview The study compares two humidity levels in incubators: one group of preemies will be in an environment with 90% humidity, while another will have a lower level of 70%. The goal is to see if higher humidity helps prevent dehydration without affecting survival or health issues.

How Is the Trial Designed?

Group I: Incubator ambient relative humidity (RH) of 90% Experimental Treatment 1 Intervention

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.

Group II: Incubator ambient relative humidity (RH) of 70% Active Control 1 Intervention

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.

Who Is Running the Clinical Trial?

The University of Texas Health Science Center, Houston

Lead Sponsor

Trials

974

Recruited

361,000+

Published Research Related to This Trial

The study developed an advanced incubator system that uses an ultrasonic nebulizer to actively control humidity levels, which is crucial for the intensive care of newborns and premature babies.

The system employs a PIC microcontroller for precise measurement and control of humidity, allowing for effective therapeutic and diagnostic applications in medical settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Humidity control of an incubator using the microcontroller-based active humidifier system employing an ultrasonic nebulizer. Güler, I., Burunkaya, M.[2004]

All neonatal intensive care units (NICUs) in the Australian and New Zealand Neonatal Network routinely use supplemental humidity for preterm infants, with 77% having written protocols to guide this practice.

There is significant variation in how NICUs implement humidification, including when to start and stop its use, highlighting the need for more research to establish standardized practices and optimize care for preterm infants.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Variability in incubator humidity practices in the management of preterm infants. Sinclair, L., Crisp, J., Sinn, J.[2015]

In a study of 20 extremely low-birthweight infants, it was found that they spent 40% of their time with relative humidity (RH) above the clinically acceptable range, indicating significant fluctuations in their microenvironment.

Despite these fluctuations, the average RH levels remained similar to the set points, suggesting that while individual care may need to be optimized, the overall humidity management was effective.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Fluctuations in relative humidity provided to extremely low-birthweight infants (R1). Kaczmarek, J., Tarawneh, A., Martins, B., et al.[2016]

Maintaining a room temperature of 32 °C and humidity of 70-80% for low birth weight neonates resulted in a cost-effective care method that could improve outcomes, as indicated by the study of 30 preterm infants.

The study recorded various health metrics, including neonatal respiratory distress syndrome and septicemia, suggesting that this approach may help reduce complications typically associated with low birth weight infants.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Role of Humidity in the Management of Premature Neonates in a Rural Incubator. Samartharam, H., Vasudeva, N., Ila, SS.[2021]

In a study involving 136 premature infants, both computer-generated and nurse-determined humidity strategies in incubators resulted in the same time to regain birthweight, with a median of 9 days for both groups.

The findings suggest that using a computer-generated humidity strategy does not provide any advantage over a nurse-determined approach in terms of weight gain for premature infants.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Computer-generated versus nurse-determined strategy for incubator humidity and time to regain birthweight. Helder, OK., Mulder, PG., van Goudoever, JB.[2016]

Maintaining incubator humidity levels between 60% to 70% during the first week of life is effective in preventing transepidermal water loss (TEWL) in preterm infants born at 26 weeks or more, which helps improve their skin barrier formation.

However, high humidity levels can increase the risk of microbial growth, indicating that while humidity is important for skin protection, it must be carefully managed to avoid potential infections.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Preterm Infant Incubator Humidity Levels: A Systematic Review. Glass, L., Valdez, A.[2023]

Increasing humidity in incubators for infants born before 30 weeks' gestation significantly reduced skin water loss and helped maintain body temperature, which is crucial for their health.

However, while humidity improved some outcomes, it also led to a higher risk of overheating and increased isolation of Pseudomonas bacteria, highlighting the need for careful monitoring of fluid balance and equipment cleanliness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Humidification of incubators. Harpin, VA., Rutter, N.[2019]

In a study of 45 preterm infants, the relative humidity (RH) in their incubators was found to be significantly lower than the recommended target of 75%, particularly on the first day of life, which led to increased body heat loss and higher metabolic costs.

The research indicates that maintaining appropriate RH levels is crucial for preterm infants, as lower humidity resulted in greater evaporative heat loss and additional energy expenditure, highlighting the need for improved nursing practices and incubator designs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Failing to meet relative humidity targets for incubated neonates causes higher heat loss and metabolic costs in the first week of life. Erbani, R., Dégrugilliers, L., Lahana, A., et al.[2019]

Citations

1. med.uth.edu med.uth.edu/pediatrics/humiditi-study/

HumidITI Study | McGovern Medical School - UTHealth Houston This study compares two commonly used humidity settings in incubators for infants <25 weeks' gestation, starting at 70% relative humidity and 90% relative ...

2. link.springer.com link.springer.com/article/10.1007/s12519-024-00818-x

Thermoregulation, incubator humidity, and skincare ... There is substantial global variation in initial incubator humidity use among extremely preterm infants (ranging from 60% to > 90%) [17].

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11956400/

The effect of incubator humidity on morbidity and mortality ... Findings revealed that a high humidity level increased the incidence of infection in preterm infants (RR = 1.26, 95% CI 1.02, 1.55, P = 0.03).

4. withpower.com withpower.com/trial/humidity-levels-in-incubators-for-preemies-5255c

Humidity Levels in Incubators for Preemies (HumidITI Trial) In a study of 45 preterm infants, the relative humidity (RH) in their incubators was found to be significantly lower than the recommended target of 75%, ...

5. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/40089583/

Insensible water loss in extremely preterm infants cared for ... Extremely preterm infants nursed in incubator with 70% RH have higher IWL than infants nursed in 90% RH.

6. sciencedirect.com sciencedirect.com/science/article/pii/S0378378222000135

Incubator humidity and temperature control in infants born ... Incubator humidity and temperature control should aid management of 22–23 GW infants to reduce IWL, facilitate skin maturation, and prevent infection.

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11269412/

Thermoregulation, incubator humidity, and skincare practices ... Without ambient humidity, the IWL is greater, which may lead to dehydration and hypernatremia (blood sodium level > 145 mmol/L) [35].