Arterial Oxygen Saturation on Ventilatory Stability in Extremely Premature Infants

NCT03695900 | Completed

• 1 other identifier: 20180536
• Study Type: interventional
• Target: 19
• Locations: 1 country
• Sites: 1

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).

Conditions

Apnea of Prematurity; Desaturation of Blood; Central Apnea; Periodic Breathing; Obstructive Apnea of Newborn

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (2)

• oxygenation stability by frequency of intermittent hypoxemia episodes

  2 hours

• frequency of bradycardia episodes

  2 hours

Study Arms (2)

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

OTHER

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%; Other: Targeting SpO2 at 90-92%

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

OTHER

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%; Other: Targeting SpO2 at 90-92%

Interventions

Targeting SpO2 at 93-95% OTHER

FiO2 adjusted to keep basal SpO2 at target range of 93-95% for 2 hours

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

Targeting SpO2 at 90-92% OTHER

FiO2 adjusted to keep basal SpO2 at target range of 90-92% for 2 hours.

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

Eligibility Criteria

• Age: Up to 18 Weeks
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• University of Miami: lead
• The Gerber Foundation: collaborator

Study Sites (1)

Holtz Children's Hospital

Miami, Florida, 33136, United States

Location

Related Publications (1)

• 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.

  PMID: 36030769 DERIVED

MeSH Terms

Conditions

Apnea; Sleep Apnea, Central

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Sleep Apnea Syndromes; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Pediatrics

Model Details: 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.

Study Record Dates

• First Submitted: October 2, 2018
• First Posted: October 4, 2018
• Study Start: November 1, 2018
• Primary Completion: November 8, 2019
• Study Completion: November 8, 2019
• Last Updated: May 10, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)