Environmental or Nasal Cannula Oxygen for Preterm Infants Receiving Oxygen Therapy: a Randomized Cross-over Pilot Study

NCT02794662 | Completed DMC

• 1 other identifier: UAB Neo 015
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to determine if, in preterm infants \< 37 weeks' gestation at birth receiving oxygen without ventilatory/CPAP support, oxygen environment (OE) compared with nasal cannula oxygen (NC), will decrease the number of episodes with oxygen saturations less than 85% of ≥10 seconds in a 48 hour cross over period on either intervention. This is a randomized cross-over pilot study with a 1:1 parallel allocation of infants to oxygen environment or nasal cannula oxygen using stratified permuted block design. Following a 24 hour period on the first intervention, infants will cross over to a 24 hour period on the second (alternative) intervention before crossing back to the first intervention for a further 24 hours and then back again to the second (alternative) intervention for a further 24 hours.

Conditions

Infant, Newborn, Diseases; Hypoxia

Keywords

Oxygen Delivery System, Nasal Cannula; Oxygen Delivery System, Incubator

Outcome Measures

Primary Outcomes (1)

• The number of episodes with oxygen saturations less than 85% for ≥10 seconds

  During a 48 hour cross-over period on either intervention

Secondary Outcomes (9)

• The proportion of time with oxygen saturations > 95%

  During a 48 hour cross-over period on either intervention

• The coefficient of variation (relative standard deviation) of oxygen saturations

  During a 48 hour cross-over period on either intervention

• The proportion of time spent outside oxygen saturation target ranges (91-95 %)

  During a 48 hour cross-over period on either intervention

• The proportion of time with oxygen saturations less than 85 %

  During a 48 hour cross-over period on either intervention

• The effective fraction of inspired oxygen (FiO2) requirement

  During a 48 hour cross-over period on either intervention

Study Arms (2)

Oxygen Environment

EXPERIMENTAL

Blended oxygen delivered by servo-controlled incubator

Procedure: Oxygen Environment

Nasal cannula oxygen

ACTIVE COMPARATOR

Blended oxygen delivered by nasal cannula

Procedure: Nasal Cannula Oxygen

Interventions

Oxygen Environment PROCEDURE

FiO2 delivered by servo-controlled incubator

Oxygen Environment

Nasal Cannula Oxygen PROCEDURE

FiO2 delivered by nasal cannula

Nasal cannula oxygen

Eligibility Criteria

• Age: 1 Hour - 6 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Infant requiring supplemental oxygen therapy via oxygen environment (OE) or nasal cannula (NC) with flow rates ≤ 1.0 liter per kilogram per minute
• Off ventilatory support and/or NCPAP for \> 48 hours prior to study entry
• Gestational age \< 37 weeks' gestation at birth
• Nursed in incubator for thermoregulation
• Parents/legal guardians have provided consent for enrollment

You may not qualify if:

• A major malformation
• A neuromuscular condition that affects respiration
• Terminal illness or decision to withhold or limit support

Sponsors & Collaborators

• University of Alabama at Birmingham: lead

Study Sites (1)

University of Alabama at Birmingham

Birmingham, Alabama, 35249, United States

Location

Related Publications (1)

• Travers CP, Carlo WA, Nakhmani A, Bhatia S, Gentle SJ, Amperayani VA, Indic P, Aban I, Ambalavanan N. Environmental or Nasal Cannula Supplemental Oxygen for Preterm Infants: A Randomized Cross-Over Trial. J Pediatr. 2018 Sep;200:98-103. doi: 10.1016/j.jpeds.2018.03.010. Epub 2018 Apr 25.

  PMID: 29705116 DERIVED

MeSH Terms

Conditions

Infant, Newborn, Diseases; Hypoxia

Condition Hierarchy (Ancestors)

Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Colm P Travers, MB BCh BAO

  University of Alabama at Birmingham

  PRINCIPAL INVESTIGATOR

• Waldemar A Carlo, MD

  University of Alabama at Birmingham

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: May 10, 2016
• First Posted: June 9, 2016
• Study Start: April 1, 2016
• Primary Completion: September 1, 2016
• Study Completion: September 1, 2016
• Last Updated: December 1, 2016

Record last verified: 2016-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)