High Flow Nasal Cannula in Comparison With Nasal Continuous Positive Airway Pressure in the Management of Respiratory Distress Syndrome

Respiratory Distress Syndrome Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02587832
• Other study ID #: 081110
• Status: Completed
• Phase: N/A
• First received: October 20, 2015
• Last updated: October 25, 2015
• Start date: July 2009
• Est. completion date: April 2012

Study information

• Verified date: October 2015
• Source: Sidra Medical and Research Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: April 2012
• Est. primary completion date: April 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Respiratory Distress Syndrome
• Respiratory Distress Syndrome, Adult
• Respiratory Distress Syndrome, Newborn
• Syndrome

Intervention

Device:
• HHHFNC
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
• NCPAP
Bubble CPAP System.

Locations

Country	Name	City	State
United States	Akron Children's Hospital	Akron	Ohio

Sponsors (2)

Lead Sponsor	Collaborator
Sidra Medical and Research Center	Akron Children's Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	the need for re-intubation	The primary outcome measured was failed extubation defined by the need for re-intubation and mechanical ventilation within five days of initial extubation.	5 DAYS	No
Secondary	Duration of respiratory support using HHHFNC /NCPAP.		through study completion, an average of 1 year.	No
Secondary	Incidence of nasal breakdown		through study completion, an average of 24 weeks	No
Secondary	sepsis		through study completion, an average of 1 year.	No
Secondary	intraventricular hemorrhage (IVH),		through study completion, an average of 24 weeks	No
Secondary	retinopathy of prematurity (ROP)	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.	through study completion, an average of 24 weeks	No