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Arterial Oxygen Saturation on Ventilatory Stability in Extremely Premature Infants

Primary Purpose

Apnea of Prematurity, Desaturation of Blood, Central Apnea

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Targeting SpO2 at 93-95%
Targeting SpO2 at 90-92%
Sponsored by
University of Miami
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Apnea of Prematurity

Eligibility Criteria

undefined - 18 Weeks (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 23 0/7- 29 6/7 weeks gestational age
  • Postnatal age ≥ 14 days
  • Requiring FiO2 ≥ 0.25 to keep SpO2 90-95%
  • Parental informed consent

Exclusion Criteria:

  • Severe congenital anomalies that may affect pulmonary or neurosensory development
  • Severe CNS pathology that may alter respiratory control function

Sites / Locations

  • Holtz Children's Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Other

Arm Label

Targeting SpO2 at 93-95% followed by targeting at 90-92%

Targeting SpO2 at 90-92% followed by targeting at 93-95%

Arm Description

FiO2 adjusted to keep basal SpO2 at target range of 93-95% for 2 hours, followed by FiO2 adjusted to keep basal SpO2 at target range of 90-92% for 2 hours.

FiO2 adjusted to keep basal SpO2 at target range of 90-92% for 2 hours, followed by FiO2 adjusted to keep basal SpO2 at target range of 93-95% for 2 hours.

Outcomes

Primary Outcome Measures

ventilatory stability by frequency of central apnea
by frequency of central apnea
ventilatory stability by frequency of obstructive apnea
by frequency of obstructive apnea
ventilatory stability by density of periodic breathing
by density of periodic breathing
ventilatory stability by time series of inter-breath intervals
by time series of inter-breath intervals

Secondary Outcome Measures

oxygenation stability by frequency of intermittent hypoxemia episodes
frequency of episodes with SpO2 < 80%
frequency of bradycardia episodes
frequency of episodes with HR < 100 bpm

Full Information

First Posted
October 2, 2018
Last Updated
May 9, 2023
Sponsor
University of Miami
Collaborators
The Gerber Foundation
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1. Study Identification

Unique Protocol Identification Number
NCT03695900
Brief Title
Arterial Oxygen Saturation on Ventilatory Stability in Extremely Premature Infants
Official Title
Impact of Arterial Oxygen Saturation Range on Ventilatory Stability in Extremely Premature Infants
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Completed
Study Start Date
November 1, 2018 (Actual)
Primary Completion Date
November 8, 2019 (Actual)
Study Completion Date
November 8, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Miami
Collaborators
The Gerber Foundation

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
This is a prospective crossover study to compare the within-subject effect of the two target ranges of arterial oxygen saturation (SpO2), both within the clinically recommended range of 90- 95%. The specific objective of this study to evaluate the impact of targeting SpO2 within 93-95% compared to the 90-92% range on ventilatory stability in premature infants of 23-29 weeks gestational age (GA).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Apnea of Prematurity, Desaturation of Blood, Central Apnea, Periodic Breathing, Obstructive Apnea of Newborn

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Model Description
This is a prospective crossover study to compare the within-subject effect of the two target ranges of arterial oxygen saturation (SpO2, 93-95% vs 90-92%) on ventilatory stability in premature infants.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
19 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Targeting SpO2 at 93-95% followed by targeting at 90-92%
Arm Type
Other
Arm Description
FiO2 adjusted to keep basal SpO2 at target range of 93-95% for 2 hours, followed by FiO2 adjusted to keep basal SpO2 at target range of 90-92% for 2 hours.
Arm Title
Targeting SpO2 at 90-92% followed by targeting at 93-95%
Arm Type
Other
Arm Description
FiO2 adjusted to keep basal SpO2 at target range of 90-92% for 2 hours, followed by FiO2 adjusted to keep basal SpO2 at target range of 93-95% for 2 hours.
Intervention Type
Other
Intervention Name(s)
Targeting SpO2 at 93-95%
Intervention Description
FiO2 adjusted to keep basal SpO2 at target range of 93-95% for 2 hours
Intervention Type
Other
Intervention Name(s)
Targeting SpO2 at 90-92%
Intervention Description
FiO2 adjusted to keep basal SpO2 at target range of 90-92% for 2 hours.
Primary Outcome Measure Information:
Title
ventilatory stability by frequency of central apnea
Description
by frequency of central apnea
Time Frame
2 hours
Title
ventilatory stability by frequency of obstructive apnea
Description
by frequency of obstructive apnea
Time Frame
2 hours
Title
ventilatory stability by density of periodic breathing
Description
by density of periodic breathing
Time Frame
2 hours
Title
ventilatory stability by time series of inter-breath intervals
Description
by time series of inter-breath intervals
Time Frame
2 hours
Secondary Outcome Measure Information:
Title
oxygenation stability by frequency of intermittent hypoxemia episodes
Description
frequency of episodes with SpO2 < 80%
Time Frame
2 hours
Title
frequency of bradycardia episodes
Description
frequency of episodes with HR < 100 bpm
Time Frame
2 hours

10. Eligibility

Sex
All
Maximum Age & Unit of Time
18 Weeks
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 23 0/7- 29 6/7 weeks gestational age Postnatal age ≥ 14 days Requiring FiO2 ≥ 0.25 to keep SpO2 90-95% Parental informed consent Exclusion Criteria: Severe congenital anomalies that may affect pulmonary or neurosensory development Severe CNS pathology that may alter respiratory control function
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nelson Claure, MSc, PhD
Organizational Affiliation
University of Miami
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Eduardo Bancalari, MD
Organizational Affiliation
University of Miami
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Deepak Jain, MD
Organizational Affiliation
University of Miami
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Waleed Kurtom, MD
Organizational Affiliation
Jackson Health System
Official's Role
Principal Investigator
Facility Information:
Facility Name
Holtz Children's Hospital
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
36030769
Citation
Kurtom W, Dormishian A, Jain D, Schott A, Aguilar AC, Grieb G, Bancalari E, Claure N. Effect of the Target Range on Arterial Oxygen Saturation Stability in Extremely Premature Infants. Neonatology. 2022;119(5):638-643. doi: 10.1159/000525271. Epub 2022 Aug 26.
Results Reference
derived

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Arterial Oxygen Saturation on Ventilatory Stability in Extremely Premature Infants

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