|- candidate number||1220|
|- NTR Number||NTR132|
|- Date ISRCTN created||20-dec-2005|
|- date ISRCTN requested||18-okt-2005|
|- Date Registered NTR||23-aug-2005|
|- Secondary IDs||N/A |
|- Public Title||Creating and maintaining functional residual capacity in preterm neonates with Respiratory Distress Syndrome.|
|- Scientific Title||Creating and maintaining functional residual capacity in preterm neonates with Respiratory Distress Syndrome.|
|- hypothesis||A sustained inflation with a mechanical device and early nasal continuous positive airway pressure is a more effective management strategy for RDS in preterm infants than conventional intervention with a self-inflating mask and bag and reduces the requirement for mechanical ventilation and surfactant treatment.|
|- Healt Condition(s) or Problem(s) studied||Preterm neonates, Respiratory distress syndrome (RDS)|
|- Inclusion criteria||Preterm neonates, gestational age range 25-32 weeks (more than 24 weeks and 6 days and not more than 32 weeks and 6 days). |
|- Exclusion criteria||Antenatal diagnosted 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 ||1-apr-2005|
|- planned closingdate||1-jul-2006|
|- Target number of participants||200|
|- Interventions||Resuscitation at birth when necessary:|
group A: prolonged inflation of 10 seconds with a mechanical device (Neopuff t-piece resuscitator) and early CPAP treatment.
group B: inflation with self-inflating mask and bag conform international resuscitation guidelines.
|- Primary outcome||Need of endotracheal intubation within 3 days after birth.|
|- Secondary outcome||1. Death;|
|- Trial web site||N/A|
|- status||stopped: trial finished|
|- 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), Department of Pediatrics|
(Source(s) of Monetary or Material Support)
|Leiden University Medical Center (LUMC)|
|- Publications||Pediatrics. 2007 Aug;120(2):322-9.|
|- Brief summary||Background:|
While advances in neonatal care have improved chances of survival of premature neonates, chronic lung disease (CLD) remains an important cause of short and long-term morbidity. Neither surfactant nor antenatal steroids have significantly decreased the incidence of bronchopulmonary dysplasia (BPD).
Although this disease seems to be multifactorial, ventilator-induced lung injury (VILI) is thought to be a major contributing factor.
To avoid VILI by mechanical ventilation, there is a growing interest for the use of nasal Continuous Positive Airway Pressure (nCPAP) to manage neonates at risk for respiratory distress syndrome (RDS) from birth.
One major issue is preventing a preterm neonate with RDS failing on nCPAP. Several causes could be responsible, but one of the main reasons is probably:
we do not create sufficient FRC at birth and we do not maintain FRC by starting CPAP as early as possible (in the delivery-room).
To investigate whether sustained inflation with a mechanical device and early nasal continuous positive airway pressure (EFURCI; early functional respiratory capacity intervention) is a more effective management strategy for RDS in preterm infants than conventional intervention (CONIN) and reduces the requirement for mechanical ventilation and surfactant treatment.
Prospective randomised controlled study.
1) preterm neonates, gestational age range 26-32 weeks (more than 25 weeks and 6 days and not more than 32 weeks and 6 days).
antenatal diagnosted congenital anomalies of the cardial or respiratory system or anomalies incompatible with survival.
Patients are included before birth. Before patients enter the study, informed consent is obtained from the infant's parents or legal guardian before. Patients are randomized to Early CPAP Intervention (group A) or Conventional Intervention (group B).
In group A, if necessary, a pressure controlled (20 cm H2O) inflation of the lungs is sustained (10 seconds), using a nasal pharyngeal tube and a T-piece mechanical ventilator. After initial inflation, a CPAP of 5-6 cm H2O will be maintained and patients will be transferred to the NICU with CPAP. Endotracheal intubation and mechanical ventilation will be performed if respiration is not sufficient.
In group B, if necessary, positive-pressure ventilation will be started with a self-inflating bag and mask during 30 seconds. Endotracheal intubation and mechanical ventilation will be performed if this method is not sufficient. Non-intubated patients will be transferred to the NICU with extra oxygen depending on the oxygen saturation measured by pulse oximetry. In the NICU supplemental oxygen or nCPAP (Infant Flow, EME Tricomed, Brighton, UK) will be given depending on the clinical judgment of the neonatologist and the severity of the RDS.
Primary end points:
need of ventilation within 3 days of birth and need of surfactant.
There is no extra risk or burden for the patients. Both methods are safely used in several clinics.
|- Main changes (audit trail)|
|- RECORD||16-aug-2005 - 26-nov-2008|