A comparison of humidified and unconditioned gases in the delivery room for stabilising preterm infants less than 30 weeks gestation at birth

A randomised controlled trial comparing the effect on admission temperature of humidified versus unconditioned gases during the stabilisation of preterm infants less than 30 weeks gestation at birth

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12613000093785

Acronym

The HUMID Study

Enrollment

268

Registered

2013-01-24

Start date

2013-02-19

Completion date

Unknown

Last updated

2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

Infants born very prematurely (under 30 weeks gestation) often require support with their breathing after birth as their lungs are stiff and they find it hard to fill them with air. In order to help infants breathe we use a flow of gas (oxygen and air) to provide pressure to help open their lungs. In this study we are comparing whether it is better to use a gas flow that has been warmed and moistened (humidified), compared to the standard method of using gas directly from the cylinder or wall (unconditioned). Humidifying gases is routine within the setting of the neonatal intensive care but is not extended to use in the delivery room setting. The purpose of this study is to find out whether the use of humidified gases in the delivery room is better in helping premature infants stay warm immediately after birth. The primary outcome will be measurement of rectal temperature on admission to the neonatal and intensive care unit (NISC).

Interventions

Infants under 30 weeks gestation who require respiratory support at birth will receive positive pressure delivered by gases (oxygen and air) that are heated and humidified using a heated humidifier unit. Infants requiring ongoing respiratory support will continue to receive heated and humidified gases during transport to the neonatal intensive and special care unit (NISC). The intervention will be given for the duration of the stabilisation in the delivery room and transport from the delivery r

Study design

Allocation

Randomised controlled trial

Intervention model

Parallel

Primary purpose

Treatment

Masking

Open (masking not used)

Eligibility

Sex/Gender

All

Age

23 Weeks to 29 Weeks

Healthy volunteers

Inclusion criteria

Preterm infants less than 30 weeks gestation born in the participating centres

Exclusion criteria

Maternal pyrexia greater than 38.0 degrees celsius within 4 hours of birth. Consent not obtained Imperforate anus (this will be a post randomisation exclusion) No requirement for respiratory support (this will be a post randomisation exclusion)

Outcome results