Respiratory Distress Syndrome Clinical Trial
Official title:
Sustained Lung Inflation at Birth for Preterm Infants at Risk of Respiratory Distress Syndrome: the Proper Pressure and Duration: Prospective Randomized Study
Verified date | April 2018 |
Source | Mansoura University Children Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The appropriate pressure and duration needed for sustained lung inflation in preterm infants at risk of respiratory distress syndrome have not been well evaluated. We aim for evaluating two different pressures, 20 and 15 cm H2O, for two different duration, 10 and 20 seconds, during the application of sustained lung inflation in the resuscitation of preterm infants with respiratory distress in the delivery room.
Status | Completed |
Enrollment | 100 |
Est. completion date | October 2016 |
Est. primary completion date | October 2016 |
Accepts healthy volunteers | No |
Gender | All |
Age group | N/A to 1 Day |
Eligibility |
Inclusion Criteria: Preterm infants with gestational age = 32 weeks' gestation, presented with respiratory distress syndrome at birth Exclusion Criteria: 1. - Preterm infants with no manifestations of respiratory distress syndrome at birth. 2. - Presence of major congenital malformation (dysmorphic features or anomalies incompatible with life) . |
Country | Name | City | State |
---|---|---|---|
Egypt | Mansoura University Children Hospital | Mansoura | El Dakahlya |
Lead Sponsor | Collaborator |
---|---|
Mansoura University Children Hospital |
Egypt,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | The need for endotracheal intubation in the delivery room | One hour | ||
Secondary | The need for mechanical ventilation | 72 hours | ||
Secondary | Need of surfactant | 72 hours | ||
Secondary | Neonatal mortality | Death before hospital discharge | 90 days | |
Secondary | Broncho Pulmonary Dysplasia ( BPD ) | Requirement for oxygen therapy more than 30% by 36 weeks corrected gestational age | 90 days | |
Secondary | Intra-Ventricular Hemorrhage ( IVH ) | 14 days | ||
Secondary | Retinopathy of Prematurity ( ROP ) | 50 days | ||
Secondary | Necrotizing Entero Colitis ( NEC ) | 40 days | ||
Secondary | Length of neonatal intensive care ( NICU ) and hospital stay | 90 days | ||
Secondary | Air-leak syndrome | Development of pneumothorax or pneumomediastinum | 14 days |
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