Respiratory Distress Syndrome
Conditions
Keywords
cpap, HHHFNC, RDS, ELBW
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.
Interventions
DEVICEHHHFNC
Tri-Anim Vaptherm the Precision Flow, which is a self contained unit that provides flow rates up to or 8 LPM (Infants) of blended oxygen that is heated and humidified
DEVICENCPAP
Bubble CPAP System.
Sponsors
Akron Children's Hospital
Sidra Medicine
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Investigator)
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| the need for re-intubation | 5 DAYS | The primary outcome measured was failed extubation defined by the need for re-intubation and mechanical ventilation within five days of initial extubation. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Duration of respiratory support using HHHFNC /NCPAP. | through study completion, an average of 1 year. | — |
| Incidence of nasal breakdown | through study completion, an average of 24 weeks | — |
| sepsis | through study completion, an average of 1 year. | — |
| intraventricular hemorrhage (IVH), | through study completion, an average of 24 weeks | — |
| retinopathy of prematurity (ROP) | through study completion, an average of 24 weeks | number of participants with sepsis will be compared between the two arms. Sepsis was defined as a positive culture result from blood with concomitant clinical symptoms. Positive cultures were defined as having positive growth from the cerebrospinal fluid, tracheal, blood, or urine specimens. |
Countries
United States
Outcome results
None listed