Arterial Oxygen Saturation on Ventilatory Stability in Extremely Premature Infants

Sponsor:

Collaborators:

Information provided by (Responsible Party):

Nelson Claure，University of Miami

Tracking Information

First Submitted Date ^ICMJE

October 2, 2018

First Posted Date ^ICMJE

October 4, 2018

Last Update Posted Date

October 4, 2018

Actual Study Start Date ^ICMJE

October 31, 2018

Estimated Primary Completion Date

October 31, 2019 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

ventilatory stability by frequency of central apnea[ Time Frame: 2 hours ]

ventilatory stability by frequency of obstructive apnea[ Time Frame: 2 hours ]

ventilatory stability by density of periodic breathing[ Time Frame: 2 hours ]

ventilatory stability by time series of inter-breath intervals[ Time Frame: 2 hours ]

Original Primary Outcome Measures ^ICMJE

Same as current

Current Secondary Outcome Measures ^ICMJE

oxygenation stability by frequency of intermittent hypoxemia episodes[ Time Frame: 2 hours ]
frequency of episodes with SpO2 < 80%
frequency of bradycardia episodes[ Time Frame: 2 hours ]
frequency of episodes with HR < 100 bpm

Descriptive Information

Brief Title ^ICMJE

Arterial Oxygen Saturation on Ventilatory Stability in Extremely Premature Infants

Official Title ^ICMJE

Impact of Arterial Oxygen Saturation Range on Ventilatory Stability in Extremely Premature Infants

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).

Detailed Description

Study Type ^ICMJE

Interventional

Study Phase

N/A

Study Design ^ICMJE

Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention 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: Interventional
Masking Description:
Primary Purpose: Other

Condition ^ICMJE

Intervention ^ICMJE

Other: Targeting SpO2 at 93-95%
FiO2 adjusted to keep basal SpO2 at target range of 93-95% for 2 hours
Other: Targeting SpO2 at 90-92%
FiO2 adjusted to keep basal SpO2 at target range of 90-92% for 2 hours.

Study Arms

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

Recruitment Information

Recruitment Status ^ICMJE

Not yet recruiting

Estimated Enrollment ^ICMJE

Original Estimated Enrollment ^ICMJE

Same as current

Estimated Study Completion Date

October 31, 2019

Estimated Primary Completion Date

October 31, 2019 (Final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Sex/Gender

Sexes Eligible for Study:

All

Ages

N/A and older (Adult, Older Adult)

Accepts Healthy Volunteers

Listed Location Countries ^ICMJE

United States

Removed Location Countries

Administrative Information

Has Data Monitoring Committee

U.S. FDA-regulated Product

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

Plan to Share IPD:

Responsible Party

Nelson Claure，University of Miami

Study Sponsor ^ICMJE

University of Miami

Collaborators ^ICMJE

Investigators ^ICMJE

Principal Investigator: Nelson Claure, MSc, PhD University of Miami
Principal Investigator: Eduardo Bancalari, MD University of Miami
Principal Investigator: Deepak Jain, MD University of Miami
Principal Investigator: Waleed Kurtom, MD Jackson Health System

PRS Account

University of Miami

Verification Date

October 2018

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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