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

NCT02819050 | Completed Results

• 1 other identifier: 30166-01
• Study Type: interventional
• Target: 80
• Locations: 0 countries
• Sites: N/A

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• 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.

  7 days

Secondary Outcomes (7)

• Number of Participants With Bronchopulmonary Dysplasia

  1-2 months

• Number of Participants With Retinopathy of Prematurity (ROP)

  1-2 months

• Number of Participants With Periventricular Leukomalacia (PVL)

  1-2 months

• Length of Stay (Days)

  60-108 days

• Corrected Gestational Age at Time of Discharge/Transfer

  36weeks-41weeks

Study Arms (2)

Sprinting

EXPERIMENTAL

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)

Device: NCPAP

Non-Sprinting

ACTIVE COMPARATOR

* 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.

Device: NCPAP

Interventions

NCPAP DEVICE

Nasal Continuous Positive Airway Pressure

Non-Sprinting; Sprinting

Eligibility Criteria

• Age: 26 Weeks+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center: lead
• Children's Hospital of Orange County: collaborator

Related Publications (10)

• 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.

  PMID: 20472939 BACKGROUND

• Finer NN, Carlo WA, Duara S, Fanaroff AA, Donovan EF, Wright LL, Kandefer S, Poole WK; National Institute of Child Health and Human Development Neonatal Research Network. Delivery room continuous positive airway pressure/positive end-expiratory pressure in extremely low birth weight infants: a feasibility trial. Pediatrics. 2004 Sep;114(3):651-7. doi: 10.1542/peds.2004-0394.

  PMID: 15342835 BACKGROUND

• Vaucher YE, Peralta-Carcelen M, Finer NN, Carlo WA, Gantz MG, Walsh MC, Laptook AR, Yoder BA, Faix RG, Das A, Schibler K, Rich W, Newman NS, Vohr BR, Yolton K, Heyne RJ, Wilson-Costello DE, Evans PW, Goldstein RF, Acarregui MJ, Adams-Chapman I, Pappas A, Hintz SR, Poindexter B, Dusick AM, McGowan EC, Ehrenkranz RA, Bodnar A, Bauer CR, Fuller J, O'Shea TM, Myers GJ, Higgins RD; SUPPORT Study Group of the Eunice Kennedy Shriver NICHD Neonatal Research Network. Neurodevelopmental outcomes in the early CPAP and pulse oximetry trial. N Engl J Med. 2012 Dec 27;367(26):2495-504. doi: 10.1056/NEJMoa1208506.

  PMID: 23268664 BACKGROUND

• Singh SD, Bowe L, Clarke P, Glover K, Pasquill A R, MJ et al. Is decreasing pressure or increasing time off the better strategy in weaning VLBW infants from nasal CPAP? Eur J Pediatr B Abstr Eur Acad Pediatr. 2006;Abstract.

  BACKGROUND

• A Soe, J Hodgkinson, B Jani DAD. Nasal continous positive airway pressure weaning in preterm infants. Eur J Pediatr B Abstr Eur Acad Pediatr. 2006;Abstract.

  BACKGROUND

• Todd DA, Wright A, Broom M, Chauhan M, Meskell S, Cameron C, Perdomi AM, Rochefort M, Jardine L, Stewart A, Shadbolt B. Methods of weaning preterm babies <30 weeks gestation off CPAP: a multicentre randomised controlled trial. Arch Dis Child Fetal Neonatal Ed. 2012 Jul;97(4):F236-40. doi: 10.1136/adc.2011-300133. Epub 2012 May 18.

  PMID: 22611116 BACKGROUND

• Jardine LA, Inglis GD, Davies MW. Strategies for the withdrawal of nasal continuous positive airway pressure (NCPAP) in preterm infants. Cochrane Database Syst Rev. 2011 Feb 16;(2):CD006979. doi: 10.1002/14651858.CD006979.pub2.

  PMID: 21328289 BACKGROUND

• Rastogi S, Rajasekhar H, Gupta A, Bhutada A, Rastogi D, Wung JT. Factors Affecting the Weaning from Nasal CPAP in Preterm Neonates. Int J Pediatr. 2012;2012:416073. doi: 10.1155/2012/416073. Epub 2011 Dec 8.

  PMID: 22187570 BACKGROUND

• Rastogi S, Wong W, Gupta A, Bhutada A; Deepa Rastogi; Maimonides Neonatal Group. Gradual versus sudden weaning from nasal CPAP in preterm infants: a pilot randomized controlled trial. Respir Care. 2013 Mar;58(3):511-6. doi: 10.4187/respcare.01999.

  PMID: 22906960 BACKGROUND

• Eze N, Murphy D, Dhar V, Rehan VK. Comparison of sprinting vs non-sprinting to wean nasal continuous positive airway pressure off in very preterm infants. J Perinatol. 2018 Feb;38(2):164-168. doi: 10.1038/jp.2017.161. Epub 2017 Oct 26.

  PMID: 29072676 DERIVED

MeSH Terms

Conditions

Respiratory Distress Syndrome, Newborn; Bronchopulmonary Dysplasia; Premature Birth

Condition Hierarchy (Ancestors)

Respiratory Distress Syndrome; Lung Diseases; Respiratory Tract Diseases; Respiration Disorders; Infant, Premature, Diseases; Infant, Newborn, Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Ventilator-Induced Lung Injury; Lung Injury; Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Limitations and Caveats

Limitations: 1. A non-blinded study. 2. Relative imbalance in the number of infants included at the two study sites 3. Inadequate sample size for data analysis based on GA sub-stratification.

Results Point of Contact

• Title: Virender Rehan
• Organization: Los Angeles Biomedical Research Institute at Harbor UCLA Medical Center

vrehan@labiomed.org

3102221965

Study Officials

• Virender Rehan, MD

  University of California, Los Angeles

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

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: Chair, Department of Neonatology

Study Record Dates

• First Submitted: May 24, 2016
• First Posted: June 30, 2016
• Study Start: January 1, 2014
• Primary Completion: January 1, 2016
• Study Completion: January 1, 2016
• Last Updated: December 10, 2021
• Results First Posted: December 10, 2021

Record last verified: 2021-12

Data Sharing

• IPD Sharing: Will not share