Clinical trial NCT04699708: Co2 Monitoring at Preterm Delivery-Observational Study
Official title: Carbon -Di-Oxide Monitoring During Neonatal STAbilization at Delivery
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Resuscitation
Keywords: Carbon dioxide monitoring
Preterm
Resuscitation
Lead sponsor: South Tees Hospitals NHS Foundation Trust
Sponsor class: OTHER
First posted: 2021-01-07
Enrollment: 150
Sex: ALL
Minimum age (years): 23
Maximum age (years): 32
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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.

Brief summary: 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.

Detailed 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.

Eligibility criteria: 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).

Primary outcomes:
measure: Factors influencing carbon dioxide levels during preterm resuscitation
timeFrame: 1 year
Secondary outcomes:
measure: Correlation of Co2 with other parameters
timeFrame: 1 year
Other outcomes:
Locations:
city: Middlesbrough
country: United Kingdom
facility: James Cook University Hospital
state: Stockton ON TEES
city: Sunderland
country: United Kingdom
facility: Imran Ahmed
Study officials:
References: