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Effective Approaches & Strategies to Ease Off Nasal CPAP In Preterm Infants (EASEOFFNCPAP)

Primary Purpose

Neonatal Respiratory Distress Syndrome, Extremely Low Birth Weight Infant (ELBW), BronchoPulmonary Dysplasia

Status

Completed

Phase

Not Applicable

Locations

Study Type

Interventional

Intervention

NCPAP

About this trial

This is an interventional supportive care trial for Neonatal Respiratory Distress Syndrome focused on measuring CPAP, Extremely Low Birth Weight Infant (ELBW), Non-invasive respiratory support, Premature infants, Non invasive ventilation weaning

Eligibility Criteria

26 Weeks - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Born between 23 0/7 - 30 6/7 weeks GA
At least 26 0/7 weeks corrected GA.
On NCPAP for at least 24 hours
Stable on ≤0.3 FiO2 for at least 24 hours

Initiation of study protocol, i.e., weaning from NCPAP, was started when infant met all of the following criteria for at least 24 hours:

Requiring NCPAP of 4-6 cm of H2O and FiO2 ≤0.3.
All babies < 32 weeks corrected GA should have been loaded or already on maintenance caffeine (caffeine citrate 20 mg/kg as the loading and 5-10 mg/kg as the maintenance dose).
Stable respiratory system assessment (respiratory rate of < 70/min, no significant chest retractions (sternal/ diaphragmatic), and baseline oxygen saturation > 86%) and otherwise deemed clinically stable for weaning off non-invasive ventilation by medical team
If post-surgery, infant must be at least 2 weeks post-operative and off antibiotics with no concern or need for repeat surgery.
A documented hemoglobin of more than 8 g/dl within 7 days of initiation of the study.
Meeting "stability criteria" defined below:
- The infant had to be tolerating a flow of no more than 2 liters NC on a FiO2 of 0.30 or less to keep oxygen saturations above 85% (should match what you wrote below in failure criteria)%.
- Have a respiratory rate of less than 70 on average over 24 hours for more than 24 hours
- The infant could have no significant chest recession (sternal/diaphragmatic)

Exclusion Criteria:

Evidence of a hemodynamically or clinically significant (worsening respiratory status or pulmonary edema on chest x-ray) Patent ductus arteriosus, diagnosed either clinically or echocardiographically.
- Any significant congenital abnormality (abnormalities affecting a major organ system, airway, or musculoskeletal system).
- Hemodynamic/respiratory instability or currently being treated for suspected or proven sepsis (positive blood culture)
- Grade IV intraventricular hemorrhage
- Inability to obtain informed parental consent

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Sprinting

Non-Sprinting

Arm Description

Take off NCPAP twice daily for 3hours (day 1), Take off NCPAP twice daily for 6hours (day 2), Take off NCPAP twice daily for 9hours (day 3), Placed back on NCPAP for 24hours (day 4), Switch to nasal cannula at a flow rate of 1.5-2 L/min (day 5)

If the infant was on NCPAP 6, Infant was weaned down to CPAP 5 for 96 hours. If they met stability criteria, then infant was switched to room air (no flow) or no more than 2L NC. If the infant was on NCPAP 5, the infant was continued on CPAP 5 for 96 hours If they met stability criteria, then infant was switched to room air (no flow) or no more than 2L NC.

Outcomes

Primary Outcome Measures

Number of Participants With Successful Wean Off CPAP at the First Attempt

Measured by successful wean off CPAP on first attempt, i.e., no NCPAP requirement after 7 days on wean protocol on first attempt.

Secondary Outcome Measures

Number of Participants With Bronchopulmonary Dysplasia

Measured as an oxygen requirement at 36 weeks corrected gestational age

Number of Participants With Retinopathy of Prematurity (ROP)

Measured as clinical signs of stage 2 or above ROP on retinal exam prior to discharge

Number of Participants With Periventricular Leukomalacia (PVL)

Measured as radiologic findings of PVL noted prior to discharge

Length of Stay (Days)

Measures as the number of days patient remained hospitalized after birth at the study hospital.

Corrected Gestational Age at Time of Discharge/Transfer

Measured as the corrected gestational age at which the patient was discharged or transferred.

Number of Attempts to Wean Off CPAP

Number of attempts made to wean off CPAP

Number of Days on Protocol

Measured as the total number of days the patient was on the study protocol

Full Information

NCT ID

NCT02819050

First Posted

May 24, 2016

Last Updated

December 8, 2021

Sponsor

Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center

Collaborators

Children's Hospital of Orange County

1. Study Identification

Unique Protocol Identification Number

NCT02819050

Brief Title

Effective Approaches & Strategies to Ease Off Nasal CPAP In Preterm Infants

Acronym

EASEOFFNCPAP

Official Title

A Prospective Randomized Controlled Tiral Comparing Sprinting Versus Non-sprinting Approach to Wean Nasal Continous Positive Airway Pressure Support in Premature Infants Born at Less Than 30 Weeks Gestational Age

Study Type

Interventional

2. Study Status

Record Verification Date

December 2021

Overall Recruitment Status

Completed

Study Start Date

January 2014 (undefined)

Primary Completion Date

January 2016 (Actual)

Study Completion Date

January 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center

Collaborators

Children's Hospital of Orange County

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

Though Nasal Continuous Positive Airway Pressure (NCPAP) is a commonly used form of non-invasive neonatal respiratory support, the optimal method of weaning off NCPAP is not well established. In this prospective, two-center randomized control trial we hypothesize that gradually increasing time off NCPAP (sprinting) increases the success of weaning NCPAP off in infants born between 23 0/7-30 6/7 weeks of gestational age.

Detailed Description

Eligible infants admitted to two Neonatal Intensive Care Units (NICUs) were randomized to a sprinting (SP) vs. a non-sprinting (NSP) protocol, both over 4 days. Infants assigned to the SP group sprinted twice daily for 3h (day 1), 6h (day 2), 9h (day 3) & then 24h back on NCPAP (day 4) before switching to nasal cannula (NC) on day 5. Infants in the NSP group were maintained on NCPAP of 5 cm of water for the first 4 days before switching to NC on day 5, similar to the SP group. Infants in both groups were observed for the next 3 days (day 5-7) to ensure stability off CPAP

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Neonatal Respiratory Distress Syndrome, Extremely Low Birth Weight Infant (ELBW), BronchoPulmonary Dysplasia

Keywords

CPAP, Extremely Low Birth Weight Infant (ELBW), Non-invasive respiratory support, Premature infants, Non invasive ventilation weaning

7. Study Design

Primary Purpose

Supportive Care

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

80 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Sprinting

Arm Type

Experimental

Arm Description

Arm Title

Non-Sprinting

Arm Type

Active Comparator

Arm Description

Intervention Type

Device

Intervention Name(s)

NCPAP

Intervention Description

Nasal Continuous Positive Airway Pressure

Primary Outcome Measure Information:

Title

Number of Participants With Successful Wean Off CPAP at the First Attempt

Description

Measured by successful wean off CPAP on first attempt, i.e., no NCPAP requirement after 7 days on wean protocol on first attempt.

Time Frame

7 days

Secondary Outcome Measure Information:

Title

Number of Participants With Bronchopulmonary Dysplasia

Description

Measured as an oxygen requirement at 36 weeks corrected gestational age

Time Frame

1-2 months

Title

Number of Participants With Retinopathy of Prematurity (ROP)

Description

Measured as clinical signs of stage 2 or above ROP on retinal exam prior to discharge

Time Frame

1-2 months

Title

Number of Participants With Periventricular Leukomalacia (PVL)

Description

Measured as radiologic findings of PVL noted prior to discharge

Time Frame

1-2 months

Title

Length of Stay (Days)

Description

Measures as the number of days patient remained hospitalized after birth at the study hospital.

Time Frame

60-108 days

Title

Corrected Gestational Age at Time of Discharge/Transfer

Description

Measured as the corrected gestational age at which the patient was discharged or transferred.

Time Frame

36weeks-41weeks

Title

Number of Attempts to Wean Off CPAP

Description

Number of attempts made to wean off CPAP

Time Frame

Until completely weaned off CPAP

Title

Number of Days on Protocol

Description

Measured as the total number of days the patient was on the study protocol

Time Frame

7-10 days

10. Eligibility

Sex

All

Minimum Age & Unit of Time

26 Weeks

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Born between 23 0/7 - 30 6/7 weeks GA At least 26 0/7 weeks corrected GA. On NCPAP for at least 24 hours Stable on ≤0.3 FiO2 for at least 24 hours Initiation of study protocol, i.e., weaning from NCPAP, was started when infant met all of the following criteria for at least 24 hours: Requiring NCPAP of 4-6 cm of H2O and FiO2 ≤0.3. All babies < 32 weeks corrected GA should have been loaded or already on maintenance caffeine (caffeine citrate 20 mg/kg as the loading and 5-10 mg/kg as the maintenance dose). Stable respiratory system assessment (respiratory rate of < 70/min, no significant chest retractions (sternal/ diaphragmatic), and baseline oxygen saturation > 86%) and otherwise deemed clinically stable for weaning off non-invasive ventilation by medical team If post-surgery, infant must be at least 2 weeks post-operative and off antibiotics with no concern or need for repeat surgery. A documented hemoglobin of more than 8 g/dl within 7 days of initiation of the study. Meeting "stability criteria" defined below: The infant had to be tolerating a flow of no more than 2 liters NC on a FiO2 of 0.30 or less to keep oxygen saturations above 85% (should match what you wrote below in failure criteria)%. Have a respiratory rate of less than 70 on average over 24 hours for more than 24 hours The infant could have no significant chest recession (sternal/diaphragmatic) Exclusion Criteria: Evidence of a hemodynamically or clinically significant (worsening respiratory status or pulmonary edema on chest x-ray) Patent ductus arteriosus, diagnosed either clinically or echocardiographically. Any significant congenital abnormality (abnormalities affecting a major organ system, airway, or musculoskeletal system). Hemodynamic/respiratory instability or currently being treated for suspected or proven sepsis (positive blood culture) Grade IV intraventricular hemorrhage Inability to obtain informed parental consent

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Virender Rehan, MD

Organizational Affiliation

University of California, Los Angeles

Official's Role

Principal Investigator

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

20472939

Citation

SUPPORT Study Group of the Eunice Kennedy Shriver NICHD Neonatal Research Network; Finer NN, Carlo WA, Walsh MC, Rich W, Gantz MG, Laptook AR, Yoder BA, Faix RG, Das A, Poole WK, Donovan EF, Newman NS, Ambalavanan N, Frantz ID 3rd, Buchter S, Sanchez PJ, Kennedy KA, Laroia N, Poindexter BB, Cotten CM, Van Meurs KP, Duara S, Narendran V, Sood BG, O'Shea TM, Bell EF, Bhandari V, Watterberg KL, Higgins RD. Early CPAP versus surfactant in extremely preterm infants. N Engl J Med. 2010 May 27;362(21):1970-9. doi: 10.1056/NEJMoa0911783. Epub 2010 May 16. Erratum In: N Engl J Med. 2010 Jun 10;362(23):2235.

Results Reference

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15342835

Citation

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Results Reference

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Citation

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Citation

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Citation

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Results Reference

derived

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Effective Approaches & Strategies to Ease Off Nasal CPAP In Preterm Infants

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