Co2 Monitoring at Preterm Delivery-Observational Study (COSTA)

South Tees Hospitals NHS Foundation Trust

Status: Unknown

Conditions: Resuscitation

Treatments: Device: Carbon dioxide monitoring

Study type: Observational

Funder types: Other

Identifiers

NCT04699708

291372

Details and patient eligibility

About

CO2 data, serving as a proxy marker for tidal volume, might enable titration of tidal volume/pressure thereby providing optimal ventilation during neonatal resuscitation.

Currently there is insufficient data on Co2 levels for preterm babies requiring resuscitation. This study involves monitoring of CO2 during preterm stabilisation.

Full description

Measurement of exhaled CO2 in the delivery room is feasible, but clinical benefits of during neonatal transition have not been studied. Volume ventilation in the Neonatal unit has been shown to improve outcomes such BPD or death. Despite the proven benefits of volume ventilation in the neonatal unit volume guided resuscitation at birth remains an unproven and under-studied technique.

CO2 data, serving as a proxy marker for tidal volume, might enable titration of tidal volume/pressure thereby providing optimal ventilation during neonatal resuscitation. Currently there is insufficient data on Co2 levels for preterm babies requiring resuscitation. This data would help in finding out optimal resuscitation strategies (Pressures/volume, frequency of breaths) rather than providing the same for all infants throughout the process of resuscitation and would help us in better interpretation Co2 levels in the future resuscitation.

Investigators aim to study the impact of various clinical (Gestation, Birth weight, need for intubation/bag-mask ventilation) and resuscitative factors (use of inflation pressures, ventilation pressures, frequency of breaths, face mask ventilation, intubation) on CO2 during preterm stabilisation.

Enrollment: 150 estimated patients

Sex: All

Ages: 23 to 32 weeks old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. All preterm infants ≤ 32 weeks born at the study centres.
2. Needing resuscitative measures at the time of birth either in the form of face mask ventilation or intubation.

Exclusion criteria

1. Preterm infants below the threshold of viability as determined by the study team.
2. Major congenital or chromosomal abnormality (including congenital heart disease, Diaphragmatic hernia, congenital pulmonary airway malformations).
3. Severe oligohydramnios (Amniotic fluid index <5 or deep vertical pool≤2).

Trial design

150 participants in 1 patient group

Preterm infants ≤ 32 weeks

Description:

All preterm infants ≤ 32 weeks born in two study centers receiving resuscitative measures at the time of birth either in the form of face mask ventilation or intubation.

Treatment:

Device: Carbon dioxide monitoring