A Comparison of Methods of Discontinuing Nasal CPAP in Premature Infants <30 Weeks Gestation

NCT03292562 | Completed Results FDA Device

• 1 other identifier: HSC-MS-17-0334
• Study Type: interventional
• Target: 66
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to determine if among infants \<30 weeks gestational age on nasal continuous positive airway pressure (NCPAP), whether discontinuing CPAP after gradual reduction in continuous positive airway pressure (CPAP) pressure leads to successful weaning off CPAP when compared to discontinuing CPAP without weaning pressure.

Conditions

Apnea of Prematurity; Respiratory Distress Syndrome

Outcome Measures

Primary Outcomes (1)

• Number of Days on NCPAP or Mechanical Ventilation

  Subjects might go on and off NCPAP or mechanical ventilation throughout the 28 days after randomization, and the total number of days will be reported.

  from randomization until 28 days post-randomization

Secondary Outcomes (7)

• Duration of Endotracheal Ventilation

  from randomization until 28 days post-randomization

• Number of Participants Who Failed to Wean Off NCPAP

  from randomization until discharge (about 92 days)

• Number of Participants Who Developed Bronchopulmonary Dysplasia

  from randomization until discharge (about 92 days)

• Number of Participants Who Developed Necrotizing Enterocolitis

  from randomization until discharge (about 92 days)

• Number of Days of Life at Which Infant Starting Taking All Feeds by Mouth

  from randomization until discharge (about 92 days)

Study Arms (2)

Discontinue NCPAP after weaning pressures

ACTIVE COMPARATOR

After randomization, CPAP pressure will be weaned by 1 every 24hours as long as the subjects continue to meet stability criteria after each wean, until CPAP of 4. If after decrease in CPAP pressure, the subject meets CPAP failure criteria pressure will be increased back to the previous level and after stabilization for 24 hours weaning process will be started again. Once the subject meets stability criteria on CPAP of 4, NCPAP will be stopped and subject will be placed on nasal cannula (NC) according to unit guidelines (max 1 Liter flow, 30% FiO2).

Device: Discontinue NCPAP after weaning pressures

Discontinue NCPAP without weaning pressures

ACTIVE COMPARATOR

After randomization, once the subject meets stability criteria, NCPAP will be stopped and subject will be placed on nasal cannula (NC) according to unit guidelines (max 1 Liter flow, 30% FiO2).

Device: Discontinue NCPAP without weaning pressures

Interventions

Discontinue NCPAP after weaning pressures DEVICE

After randomization, CPAP pressure will be weaned by 1 every 24hours as long as the subjects continue to meet stability criteria after each wean, until CPAP of 4. If after decrease in CPAP pressure, the subject meets CPAP failure criteria pressure will be increased back to the previous level and after stabilization for 24 hours weaning process will be started again. Once the subject meets stability criteria on CPAP of 4, NCPAP will be stopped and subject will be placed on nasal cannula (NC) according to unit guidelines (max 1 Liter flow, 30% FiO2).

Discontinue NCPAP after weaning pressures

Discontinue NCPAP without weaning pressures DEVICE

After randomization, once the subject meets stability criteria, NCPAP will be stopped and subject will be placed on nasal cannula (NC) according to unit guidelines (max 1 Liter flow, 30% FiO2).

Discontinue NCPAP without weaning pressures

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• All infants \< 30 weeks by dates, on NCPAP therapy, on caffeine 10mg/kg daily
• Meet CPAP stability criteria for ≥ 12hours (CPAP 6 cm water (H2O), FiO2 \</=0.25 and stable (to maintain sats 85-95%), Respiratory rate consistently less than 60, Mild to no subcostal/intercostal retractions, No Apnea or bradycardia event that requires bag mask ventilation, Less than 3 apnea/brady/desat episodes in any 1 hour period for previous 6 hours, Tolerated time off CPAP during routine CPAP care (\~15 min)

You may not qualify if:

• Major congenital anomalies including congenital heart disease
• Anomalies that prevent discontinuation of NCPAP
• Undergoing current evaluation for and/or treatment of sepsis

Sponsors & Collaborators

• The University of Texas Health Science Center, Houston: lead

Study Sites (1)

The University of Texas Health Science Center at Houston

Houston, Texas, 77030, United States

Location

MeSH Terms

Conditions

Apnea; Respiratory Distress Syndrome

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Lung Diseases

Results Point of Contact

• Title: Amir Khan, MD
• Organization: The University of Texas Health Science Center at Houston

Amir.M.Khan@uth.tmc.edu

713-500-5519

Study Officials

• Brittany Duyka, MD

  The University of Texas Health Science Center, Houston

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: September 21, 2017
• First Posted: September 25, 2017
• Study Start: September 19, 2017
• Primary Completion: March 1, 2019
• Study Completion: March 31, 2019
• Last Updated: March 17, 2020
• Results First Posted: March 17, 2020

Record last verified: 2020-02

Locations

US (1)