Arterial Oxygen Saturation on Ventilatory Stability in Extremely Premature Infants

Not Applicable

Completed

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

• Registration Number: NCT03695900
• Lead Sponsor: University of Miami

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

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2018-10-02
• Study First Submitted QC: 2018-10-02
• Study First Posted: 2018-10-04
• Study Start: 2018-11-01
• Primary Completion: 2019-11-08
• Study Completion: 2019-11-08
• Status Verified: 2023-05
• Last Update Submitted: 2023-05-09
• Last Update Posted: 2023-05-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 19

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

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Exclusion Criteria

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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Targeting SpO2 at 90-92% followed by targeting at 93-95%	Targeting SpO2 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.
Targeting SpO2 at 93-95% followed by targeting at 90-92%	Targeting SpO2 at 93-95%	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.
Targeting SpO2 at 93-95% followed by targeting at 90-92%	Targeting SpO2 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.
Targeting SpO2 at 90-92% followed by targeting at 93-95%	Targeting SpO2 at 90-92%	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.

Primary Outcome Measures

Name	Time	Method
ventilatory stability by density of periodic breathing	2 hours	by density of periodic breathing
ventilatory stability by frequency of central apnea	2 hours	by frequency of central apnea
ventilatory stability by frequency of obstructive apnea	2 hours	by frequency of obstructive apnea
ventilatory stability by time series of inter-breath intervals	2 hours	by time series of inter-breath intervals

Secondary Outcome Measures

Name	Time	Method
frequency of bradycardia episodes	2 hours	frequency of episodes with HR \< 100 bpm
oxygenation stability by frequency of intermittent hypoxemia episodes	2 hours	frequency of episodes with SpO2 \< 80%

Trial Locations

Locations (1)

Holtz Children's Hospital; 🇺🇸 Miami, Florida, United States