Trial Outcomes & Findings for Neonatal Resuscitation - Sustained Inflations (NCT NCT02967562)

NCT ID: NCT02967562

Last Updated: 2020-11-10

Results Overview

Expiratory tidal volume during the first minute of resuscitation

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 63 participants
• Primary outcome timeframe: one minute
• Results posted on: 2020-11-10

Participant Flow

Participant milestones

Measure	Inflation Breaths Five 'inflation breaths' lasting two - three seconds Inflation Breaths	Sustained Inflation One fifteen second 'sustained inflation' Sustained Inflation
Overall Study STARTED	32	31
Overall Study COMPLETED	30	30
Overall Study NOT COMPLETED	2	1

Reasons for withdrawal

Measure	Inflation Breaths Five 'inflation breaths' lasting two - three seconds Inflation Breaths	Sustained Inflation One fifteen second 'sustained inflation' Sustained Inflation
Overall Study Consent not obtained	1	0
Overall Study High leak precluding analysis	1	1

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Measure	Inflation Breaths n=30 Participants Five 'inflation breaths' lasting two - three seconds Inflation Breaths	Sustained Inflation n=30 Participants One fifteen second 'sustained inflation' Sustained Inflation	Total n=60 Participants Total of all reporting groups
Age, Continuous	29.7 post menstrual weeks n=30 Participants	30.6 post menstrual weeks n=30 Participants	30.3 post menstrual weeks n=60 Participants
Sex: Female, Male Female	16 Participants n=30 Participants	10 Participants n=30 Participants	26 Participants n=60 Participants
Sex: Female, Male Male	14 Participants n=30 Participants	20 Participants n=30 Participants	34 Participants n=60 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.

PRIMARY outcome

Timeframe: one minute

Expiratory tidal volume during the first minute of resuscitation

Outcome measures

Measure	Inflation Breaths n=30 Participants Five 'inflation breaths' lasting two - three seconds Inflation Breaths	Sustained Inflation n=30 Participants One fifteen second 'sustained inflation' Sustained Inflation
Expiratory Tidal Volume	153 ml/kg/min Interval 18.0 to 385.0	194 ml/kg/min Interval 45.0 to 505.0

SECONDARY outcome

Timeframe: 10 minutes

end tidal carbon dioxide level during resuscitation

Outcome measures

Measure	Inflation Breaths n=30 Participants Five 'inflation breaths' lasting two - three seconds Inflation Breaths	Sustained Inflation n=30 Participants One fifteen second 'sustained inflation' Sustained Inflation
End Tidal Carbon Dioxide Level	28.6 mmHg Interval 1.9 to 46.0	34.2 mmHg Interval 1.4 to 80.5

OTHER_PRE_SPECIFIED outcome

Timeframe: 48 hours

Duration of mechanical ventilation ini first 48 hours

Outcome measures

Measure	Inflation Breaths n=30 Participants Five 'inflation breaths' lasting two - three seconds Inflation Breaths	Sustained Inflation n=30 Participants One fifteen second 'sustained inflation' Sustained Inflation
Mechanical Ventilation	32.5 hours Interval 0.0 to 48.0	17 hours Interval 0.0 to 48.0

OTHER_PRE_SPECIFIED outcome

Timeframe: First week of life

Rates of intraventricular haemorrhage, significant patent ductus arteriosus, and pneumothorax

Outcome measures

Outcome data not reported

Adverse Events

Inflation Breaths

Serious events: 0 serious events

Other events: 0 other events

Deaths: 3 deaths

Sustained Inflation

Serious events: 0 serious events

Other events: 0 other events

Deaths: 2 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Professor Anne Greenough

King's College London

Phone: 02032999000

Email: anne.greenough@kcl.ac.uk

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place