Clinical trial NCT02587832: High Flow Nasal Cannula in Comparison With Nasal Continuous Positive Airway Pressure in the Management of Respiratory Distress Syndrome
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Respiratory Distress Syndrome
Keywords: cpap
HHHFNC
RDS
ELBW
Lead sponsor: Sidra Medicine
Sponsor class: OTHER
Collaborators: name: Akron Children's Hospital
First posted: 2015-10-27
Enrollment: 60
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: the need for re-intubation
timeFrame: 5 DAYS
Secondary outcomes:
measure: Duration of respiratory support using HHHFNC /NCPAP.
timeFrame: through study completion, an average of 1 year.
measure: Incidence of nasal breakdown
timeFrame: through study completion, an average of 24 weeks
measure: sepsis
timeFrame: through study completion, an average of 1 year.
measure: intraventricular hemorrhage (IVH),
timeFrame: through study completion, an average of 24 weeks
measure: retinopathy of prematurity (ROP)
timeFrame: through study completion, an average of 24 weeks
Other outcomes:
Locations:
city: Akron
country: United States
facility: Akron Children's Hospital
state: Ohio
Study officials:
affiliation: Akron Children's Hospital
name: Mohammed Elkhwad, MD
role: PRINCIPAL_INVESTIGATOR
References: