No registrations found.
ID
Source
Brief title
Health condition
neonatal resuscitation
Sponsors and support
Intervention
Outcome measures
Primary outcome
The need for intubation in the first 24 hours after birth.
Secondary outcome
1. Oxygen saturation (SpO2) levels between 3 and 10 minutes of life, recorded by a Nellcor pulse oximeter;
2. The use of 100% oxygen in the DR;
3. Apgar score at 1 and 5 minutes, calculated from the five components of the score;
4. The need for circulatory support over first 24 hours;
5. Incidence of pulmonary air leak syndromes (pneumothorax, pulmonary interstitial emphysema, pneumomediastinum) in the first 72 hours reported by a radiologist masked to the intervention;
6. Incidence of abnormal cranial ultrasound findings:
A. All intraventricular haemorrhage;
B. Severe – ie. Papile grade III and IV - intraventricular haemorrhage;
C. Periventricular leukomalacia.
7. Duration of endotracheal (ET) ventilation (hours);
8. Duration of nasal CPAP (hours);
9. Duration of supplemental oxygen therapy (hours);
10. Total duration of assisted ventilation (ET, CPAP) in hours;
11. Incidence of bronchopulmonary dysplasia (BPD) at 36 weeks corrected gestational age defined as the need for supplementary oxygen and/or any form respiratory support;
12. Neonatal mortality - death before discharge from hospital;
13. Composite outcome of death or BPD.
Background summary
Randomised controlled trial of interface use during stabilisation of preterm infants in the delivery room.
Hypothesis:
Resuscitation of infants between 24 and 30 weeks gestation is more effective using a nasal tube than a face mask as an interface with the Neopuff Infant Resuscitator (Neopuff) as the manual ventilating device.
Aim:
To compare two resuscitation device interfaces; the nasal tube with a face mask using the Neopuff Infant Resuscitator to stabilise newly born infants between 24 and 30 weeks gestation in the delivery room (DR).
Research plan:
Infants between 24 and 30 completed weeks gestation born at Leiden University Medical Center and requiring positive pressure ventilation in the delivery room will be randomly allocated to either the nasal tube or face mask.
Primary objective:
To determine whether the response to ventilation in the DR using a nasal tube compared to a face mask reduces the risk of lung injury in newly born infants measured by the need for endotracheal intubation in the first 24 hours after birth.
Study objective
The hypothesis is that using nasal tube as interface during stabilisation of preterm infants at birth is more effective compared to mask.
Study design
1. Birth;
2. 24 hours after birth.
Intervention
During respiratory support mask or nasal tube will be used as interface. National resuscitation guidelines will be followed.
P.O. Box 9600
Arjan B. Pas, te
Leiden 2300 RC
The Netherlands
+31 (0)71 5262909
a.b.te_pas@lumc.nl
P.O. Box 9600
Arjan B. Pas, te
Leiden 2300 RC
The Netherlands
+31 (0)71 5262909
a.b.te_pas@lumc.nl
Inclusion criteria
Preterm infants, gestational age range 24-30 weeks (more than 24 weeks and not more than 29 weeks and 6 days).
Exclusion criteria
Antenatal diagnosed congenital anomalies of the cardial or respiratory system or anomalies incompatible with survival.
Design
Recruitment
Followed up by the following (possibly more current) registration
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL1944 |
| NTR-old | NTR2061 |
| CCMO | NL25699.058.08 |
| ISRCTN | ISRCTN wordt niet meer aangevraagd. |
| OMON | NL-OMON32567 |