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

Trial Summary

What is the purpose of this trial?

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.

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 data supports the effectiveness of the treatment Incubator ambient relative humidity (RH) of 70% and 90% for preemies?

Research suggests that maintaining relative humidity (RH) in incubators helps improve thermal stability and fluid balance in extremely low-birthweight infants, which are crucial for their care. Additionally, an optimal humidity protocol may reduce the time it takes for premature infants to regain their birthweight. ^{1 2 3 4 5}

Is it safe to use high humidity levels in incubators for premature babies?

Using high humidity levels in incubators for premature babies can help reduce skin water loss and maintain body temperature, but it may increase the risk of overheating and infection. Careful monitoring of fluid balance and cleanliness is important to ensure safety. ^{2 4 6 7 8}

How does the treatment of incubator humidity levels for preemies differ from other treatments?

This treatment is unique because it involves adjusting the humidity levels in incubators to 70% or 90% to help preterm infants maintain body temperature and reduce water loss through the skin. Unlike other treatments, it specifically targets the microenvironment of the incubator to improve thermal stability and fluid balance, which is crucial for the care of extremely low-birthweight infants. ^{2 3 4 5 6}

Research Team

Matthew Rysavy, MD, PhD

Principal Investigator

The University of Texas Health Science Center, Houston

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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]

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 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]

References

1. United States pubmed.ncbi.nlm.nih.gov

Computer-generated versus nurse-determined strategy for incubator humidity and time to regain birthweight. [2016]

2. England pubmed.ncbi.nlm.nih.gov

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

3. Australia pubmed.ncbi.nlm.nih.gov

Variability in incubator humidity practices in the management of preterm infants. [2015]

4. United States pubmed.ncbi.nlm.nih.gov

Preterm Infant Incubator Humidity Levels: A Systematic Review. [2023]

5. Australia pubmed.ncbi.nlm.nih.gov

Fluctuations in relative humidity provided to extremely low-birthweight infants (R1). [2016]

6. England pubmed.ncbi.nlm.nih.gov

Humidification of incubators. [2019]

7. United States pubmed.ncbi.nlm.nih.gov

The Role of Humidity in the Management of Premature Neonates in a Rural Incubator. [2021]

8. Norway 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. [2019]