Premature Birth
Conditions
Brief summary
This study compares a fifteen second sustained inflation (SI) to five repeated two - three second 'inflation breaths' during resuscitation at delivery of infants born prematurely.
Detailed description
Around 10% of newborns will require some form of assistance after delivery, with babies born more prematurely more likely to require resuscitation Current UK guidelines advise initial resuscitation with the delivery of five 'inflation breaths' lasting 2-3 seconds with peak inflation pressure of 30cmH2O (20-25cm H2O in premature neonates). Previous studies have shown that despite resuscitation training, clinicians in both simulated and real resuscitation scenarios do not deliver the recommended duration of inflation breaths. This, combined with leaks around the facemask often being as large as 50% or greater, contributes to low expired tidal volumes during resuscitation, thus increasing the likelihood of hypoxia and delay in establishing effective respiration. The use of sustained inflations (up to 15 seconds), rather than intermittent shorter inflation breaths, has shown promising results, with reduction in the need for intubation, and the need for and duration of mechanical ventilation. Around 30% of units in Germany use sustained inflations as first line delivery room management, as do many other hospitals around the world. Resuscitation guidelines from the USA, UK and Europe suggest that sustained inflations should be researched further. Several studies have shown that for several lengths of inflation breaths, the expired tidal volume achieved is higher if the baby makes respiratory effort during the inflation (active inflation) and that stimulation of spontaneous respiratory effort is a key part in establishing an FRC, enabling spontaneous breathing, and increasing the likelihood of successful resuscitation. To date, there are no studies directly comparing whether prolonged inflations are more successful at provoking an inspiration than other methods of resuscitation. We therefore aim to compare a 15 second sustained inflation to repeated shorter inflations to determine which is more effective.
Interventions
OTHERInflation Breaths
OTHERSustained Inflation
Sponsors
King's College Hospital NHS Trust
King's College London
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
0 Minutes to 1 Hours
Healthy volunteers
No
Inclusion criteria
* Infants born at less than 34 weeks gestation requiring resuscitation at delivery
Exclusion criteria
* Major congenital abnormalities * Parents have previously expressed lack of consent for study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Expiratory Tidal Volume | one minute | Expiratory tidal volume during the first minute of resuscitation |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| End Tidal Carbon Dioxide Level | 10 minutes | end tidal carbon dioxide level during resuscitation |
Other
| Measure | Time frame | Description |
|---|---|---|
| Mechanical Ventilation | 48 hours | Duration of mechanical ventilation ini first 48 hours |
| Adverse Effects | First week of life | Rates of intraventricular haemorrhage, significant patent ductus arteriosus, and pneumothorax |
Countries
United Kingdom
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Inflation Breaths Five 'inflation breaths' lasting two - three seconds
Inflation Breaths | 30 |
| Sustained Inflation One fifteen second 'sustained inflation'
Sustained Inflation | 30 |
| Total | 60 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Consent not obtained | 1 | 0 |
| Overall Study | High leak precluding analysis | 1 | 1 |
Baseline characteristics
| Characteristic | Inflation Breaths | Sustained Inflation | Total |
|---|---|---|---|
| Age, Continuous | 29.7 post menstrual weeks | 30.6 post menstrual weeks | 30.3 post menstrual weeks |
| Race and Ethnicity Not Collected | — | — | 0 Participants |
| Sex: Female, Male Female | 16 Participants | 10 Participants | 26 Participants |
| Sex: Female, Male Male | 14 Participants | 20 Participants | 34 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 3 / 32 | 2 / 31 |
| other Total, other adverse events | 0 / 32 | 0 / 31 |
| serious Total, serious adverse events | 0 / 32 | 0 / 31 |
Outcome results
Primary
Expiratory Tidal Volume
Expiratory tidal volume during the first minute of resuscitation
Time frame: one minute
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Inflation Breaths | Expiratory Tidal Volume | 153 ml/kg/min |
| Sustained Inflation | Expiratory Tidal Volume | 194 ml/kg/min |
Secondary
End Tidal Carbon Dioxide Level
end tidal carbon dioxide level during resuscitation
Time frame: 10 minutes
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Inflation Breaths | End Tidal Carbon Dioxide Level | 28.6 mmHg |
| Sustained Inflation | End Tidal Carbon Dioxide Level | 34.2 mmHg |
Other Pre-specified
Adverse Effects
Rates of intraventricular haemorrhage, significant patent ductus arteriosus, and pneumothorax
Time frame: First week of life
Other Pre-specified
Mechanical Ventilation
Duration of mechanical ventilation ini first 48 hours
Time frame: 48 hours
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Inflation Breaths | Mechanical Ventilation | 32.5 hours |
| Sustained Inflation | Mechanical Ventilation | 17 hours |