|- candidate number||6633|
|- NTR Number||NTR2061|
|- ISRCTN||ISRCTN wordt niet meer aangevraagd.|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||22-okt-2009|
|- Secondary IDs||NL25699.058.08. CCMO|
|- Public Title||Is the mask or nasal tube better as interface during respiratory support of preterm infants at birth?|
|- Scientific Title||Randomised controlled trial of interface use during stabilisation of preterm infants in the delivery room.|
|- hypothesis||The hypothesis is that using nasal tube as interface during stabilisation of preterm infants at birth is more effective compared to mask.|
|- Healt Condition(s) or Problem(s) studied||Neonatal resuscitation|
|- 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.|
|- mec approval received||yes|
|- multicenter trial||no|
|- Type||2 or more arms, randomized|
|- planned startdate ||17-mei-2009|
|- planned closingdate||17-okt-2012|
|- Target number of participants||774|
|- Interventions||During respiratory support mask or nasal tube will be used as interface. National resuscitation guidelines will be followed.|
|- 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.
|- Timepoints||1. Birth;|
2. 24 hours after birth.
|- Trial web site||N/A|
|- CONTACT FOR PUBLIC QUERIES||MD. Arjan B. Pas, te|
|- CONTACT for SCIENTIFIC QUERIES||MD. Arjan B. Pas, te|
|- Sponsor/Initiator ||Leiden University Medical Center (LUMC)|
(Source(s) of Monetary or Material Support)
|- Brief summary||Randomised controlled trial of interface use during stabilisation of preterm infants in the delivery room. |
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.
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).
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.
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.
|- Main changes (audit trail)||27-10-09: Changed inclusion criteria. |
Old criteria: Preterm infants, gestational age range 25-29 weeks (more than 25
weeks and not more than 28 weeks and 6 days).
New criteria:Preterm infants, gestational age range 25-30 weeks (more than 25 weeks and not more than 29 weeks and 6 days).
28-10-2010: Consensus changed, preterm infants of 24 weeks will be included as well - NM
05-Apr-2012: Trial has been stopped because of slow recruitment and futility - NM
|- RECORD||22-okt-2009 - 5-apr-2012|