Arterial Oxygen Saturation on Ventilatory Stability in Extremely Premature Infants

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

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).

Study Overview

• Status: Completed
• Conditions: Apnea of Prematurity; Periodic Breathing; Desaturation of Blood; Central Apnea; Obstructive Apnea of Newborn
• Intervention / Treatment: Other: Targeting SpO2 at 93-95%; Other: Targeting SpO2 at 90-92%

• Study Type: Interventional
• Enrollment (Actual): 19
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Florida
    • Miami, Florida, United States, 33136
      • Holtz Children's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 4 months (Child)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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 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.
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.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
ventilatory stability by frequency of central apnea	by frequency of central apnea	2 hours
ventilatory stability by frequency of obstructive apnea	by frequency of obstructive apnea	2 hours
ventilatory stability by density of periodic breathing	by density of periodic breathing	2 hours
ventilatory stability by time series of inter-breath intervals	by time series of inter-breath intervals	2 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
oxygenation stability by frequency of intermittent hypoxemia episodes	frequency of episodes with SpO2 < 80%	2 hours
frequency of bradycardia episodes	frequency of episodes with HR < 100 bpm	2 hours

Collaborators and Investigators

• Sponsor: University of Miami
• Collaborators: The Gerber Foundation
• Investigators: Principal Investigator: Eduardo Bancalari, MD, University of Miami; Principal Investigator: Deepak Jain, MD, University of Miami; Principal Investigator: Waleed Kurtom, MD, Jackson Health System; Principal Investigator: Nelson Claure, MSc, PhD, University of Miami

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2018
• Primary Completion (Actual): November 8, 2019
• Study Completion (Actual): November 8, 2019

Study Registration Dates

• First Submitted: October 2, 2018
• First Submitted That Met QC Criteria: October 2, 2018
• First Posted (Actual): October 4, 2018

Study Record Updates

• Last Update Posted (Actual): May 10, 2023
• Last Update Submitted That Met QC Criteria: May 9, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Respiratory Tract Diseases; Respiration Disorders; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Signs and Symptoms, Respiratory; Sleep Apnea Syndromes; Sleep Apnea, Obstructive; Apnea; Sleep Apnea, Central
• Other Study ID Numbers: 20180536

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No