High Flow Nasal Cannula in Comparison With Nasal Continuous Positive Airway Pressure in the Management of Respiratory Distress Syndrome
| Status: | Completed |
|---|---|
| Conditions: | Hospital, Pulmonary |
| Therapuetic Areas: | Pulmonary / Respiratory Diseases, Other |
| Healthy: | No |
| Age Range: | Any |
| Updated: | 4/21/2016 |
| Start Date: | July 2009 |
| End Date: | April 2012 |
Randomized Control Trial: Heated Humidity High Flow Nasal Cannula in Comparison With Nasal Continuous Positive Airway Pressure in the Management of Respiratory Distress Syndrome in Extreme Low Birth Infants in Immediate Post Extubation Period
To compare the primary outcome, failure of extubation defined by the need for re-intubation
and mechanical ventilation within 5 days of initial extubation and secondary outcomes,
morbidities and mortality after using of heated humidity high flow nasal cannula (HHHFNC)
and Nasal Continuous Positive Airway Pressure (NCPAP) in the immediate post-extubation
period for preterm infants between 24 and 28 weeks gestation with respiratory distress
syndrome.
and mechanical ventilation within 5 days of initial extubation and secondary outcomes,
morbidities and mortality after using of heated humidity high flow nasal cannula (HHHFNC)
and Nasal Continuous Positive Airway Pressure (NCPAP) in the immediate post-extubation
period for preterm infants between 24 and 28 weeks gestation with respiratory distress
syndrome.
Inclusion criteria were: 1) Preterm neonates with gestational age of 24 to 28 completed
weeks. 2) In the case of twins, both neonates were included in the same treatment arm. 3)
Success to wean with 24 hours to extubate. 4) Parental written informed consent for
participation in the study obtained on admission into the hospital or prior to delivery.
Exclusion criteria were: 1) Evidence of severe birth asphyxia. 2) Known genetic or
chromosomal disorders. 3) Infants delivered to mothers with ruptured membranes of more than
three weeks duration. 4) Potentially life-threatening conditions unrelated to prematurity.
5) Participation in another clinical trial of any placebo, drug, biological, or device
conducted under the provisions of a protocol.
Randomization A computer-generated block-randomization sequence with random block sizes was
used. Infants who were part of multiple births underwent individual randomization.
Clinicians opened consecutively numbered, sealed, brown envelopes immediately before
extubation to determine the study-group assignment.
weeks. 2) In the case of twins, both neonates were included in the same treatment arm. 3)
Success to wean with 24 hours to extubate. 4) Parental written informed consent for
participation in the study obtained on admission into the hospital or prior to delivery.
Exclusion criteria were: 1) Evidence of severe birth asphyxia. 2) Known genetic or
chromosomal disorders. 3) Infants delivered to mothers with ruptured membranes of more than
three weeks duration. 4) Potentially life-threatening conditions unrelated to prematurity.
5) Participation in another clinical trial of any placebo, drug, biological, or device
conducted under the provisions of a protocol.
Randomization A computer-generated block-randomization sequence with random block sizes was
used. Infants who were part of multiple births underwent individual randomization.
Clinicians opened consecutively numbered, sealed, brown envelopes immediately before
extubation to determine the study-group assignment.
Inclusion Criteria:
1. Preterm neonates with gestational age of 24 to 28 completed weeks.
2. In the case of twins, both neonates were included in the same treatment arm.
3. Success to wean with 24 hours to extubate.
4. Parental written informed consent for participation in the study obtained on
admission into the hospital or prior to delivery.
Exclusion Criteria:
1. Evidence of severe birth asphyxia.
2. Known genetic or chromosomal disorders.
3. Infants delivered to mothers with ruptured membranes of more than three weeks
duration.
4. Potentially life-threatening conditions unrelated to prematurity.
5. Participation in another clinical trial of any placebo, drug, biological, or device
conducted under the provisions of a protocol.
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Akron Children's Hospital From humble beginnings as a day nursery in 1890, Akron Children
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