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Air for Infant Resuscitation

The Air Study: Air for Infant Resuscitation, an observational cohort study of short term birth outcomes in moderate-late preterm infants

Status
Completed
Phases
Unknown
Study type
Observational
Source
ANZCTR
Registry ID
ACTRN12620001252909
Acronym
AIR
Enrollment
79
Registered
2020-11-23
Start date
2021-02-20
Completion date
2022-12-19
Last updated
2023-03-06

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

Conditions

None listed

Brief summary

AIR is an observational study that aims to determine if oxygen saturations (SpO2) of newborn infants 32 to 36 weeks gestation can reach recommended levels suggested by international expert guidelines. Currently, international guidelines recommend that respiratory support for newborn infants at or above 35 weeks gestation and those between 32-34 weeks gestation be initiated with air (21% oxygen) and 21-30% oxygen, respectively. For the first 10 minutes of life, guidelines also recommend that the amount of oxygen given to the infants should be adjusted to target SpO2 of healthy, full-term infants. This is part of multicentre study of hospitals in New South Wales Australia aiming to recruit 200 babies.

Interventions

Observations will be recorded by a person uninvolved in the clinical care of the infant and verified by stored data (except FiO2) on the oximeters. Variables are: First 10 minutes - 1. Time of delivery of body 2. Time of cord clamping 3. FiO2, SpO2 and heart rate for every minute after cord clamping for 10 minutes 4. Type and timing of cardiorespiratory intervention Prior to leaving the delivery room and at 24 hours of age - 1. Birth outcome (deceased/alive/transferred to nursery/well infant, n

Observations will be recorded by a person uninvolved in the clinical care of the infant and verified by stored data (except FiO2) on the oximeters. Variables are: First 10 minutes - 1. Time of delivery of body 2. Time of cord clamping 3. FiO2, SpO2 and heart rate for every minute after cord clamping for 10 minutes 4. Type and timing of cardiorespiratory intervention Prior to leaving the delivery room and at 24 hours of age - 1. Birth outcome (deceased/alive/transferred to nursery/well infant, no further medical care needed) 2. Type of cardiorespiratory support (if applicable) 3. Presence of cardiopulmonary pathology (if known). Observations will cease at 24 hours because the majority (>80%) of newborn deaths will occur in the first day of life (WHO, n.d.). Cardiopulmonary pathology will be defined as 1. The need for supplemental oxygen to maintain SpO2 > 95% and/or 2. The need for mechanical ventilatory support after delivery room stabilization and/or 3. Structural anatomical lesions that interfere with oxygenation e.g. cyanotic heart disease. Infants will be excluded if there is no personnel to collect data or if equipment is unavailable. References World Health Organisation. Guidelines on basic newborn resuscitation. Available from: https://www.who.int/maternal_child_adolescent/documents/who_rht_msm_981/en/ Accessed 24 April 2020.

Sponsors

Royal Hospital for Women
Lead SponsorHospital

Eligibility

Sex/Gender
All
Age
32 Weeks to 36 Weeks
Healthy volunteers
No

Inclusion criteria

Any live born infant 32+0 to 36+6 weeks gestation requiring respiratory support in the delivery room/operating theatre.

Exclusion criteria

Lack of personnel or appropriate equipment (including oximetry and oxygen blenders) to record data

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 6, 2026