Co2 Monitoring at Preterm Delivery-Observational Study

Study Overview
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Brief Summary
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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
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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.

Official Title
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Carbon -Di-Oxide Monitoring During Neonatal STAbilization at Delivery

Conditions
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Resuscitation

Intervention / Treatment
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* Device: Carbon dioxide monitoring


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: All preterm infants ≤ 32 weeks born at the study centres. Needing resuscitative measures at the time of birth either in the form of face mask ventilation or intubation. Exclusion Criteria: Preterm infants below the threshold of viability as determined by the study team. Major congenital or chromosomal abnormality (including congenital heart disease, Diaphragmatic hernia, congenital pulmonary airway malformations). Severe oligohydramnios (Amniotic fluid index <5 or deep vertical pool≤2).

Ages Eligible for Study
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Minimum Age: 23 Weeks
Maximum Age: 32 Weeks

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Preterm infants ≤ 32 weeks<br>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. | Device: Carbon dioxide monitoring<br>* Blinded recording of CO2 during preterm resuscitation.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Factors influencing carbon dioxide levels during preterm resuscitation | To study the impact/correlation of various clinical factors (Gestation, Birth weight, need for intubation/bag-mask ventilation, surfactant administration, delayed cord clamping) and resuscitative factors (use of inflation pressures, ventilation pressures, frequency of breaths, face mask ventilation, intubation) on carbon dioxide measurements using MASIMO NOMOLINE capnography during preterm stabilisation. | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Correlation of Co2 with other parameters | Correlation between oxygen saturation, CO2 and pulse rate. | 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Carbon dioxide monitoring, Preterm, Resuscitation