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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%

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

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

NCT ID

NCT03695900

First Posted

October 2, 2018

Last Updated

May 9, 2023

Sponsor

University of Miami

Collaborators

The Gerber Foundation

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

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

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

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

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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