Arterial Oxygen Saturation on Ventilatory Stability in Extremely Premature Infants

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

19 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-11-01

Study Completion Date

2019-11-08

Brief Summary

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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).

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Detailed Description

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Conditions

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

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.

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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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.

Group Type OTHER

Targeting SpO2 at 93-95%

Intervention Type OTHER

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

Targeting SpO2 at 90-92%

Intervention Type 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%

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.

Group Type OTHER

Targeting SpO2 at 93-95%

Intervention Type OTHER

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

Targeting SpO2 at 90-92%

Intervention Type OTHER

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

Interventions

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Targeting SpO2 at 93-95%

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

Intervention Type OTHER

Targeting SpO2 at 90-92%

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

Intervention Type OTHER

Eligibility Criteria

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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

Maximum Eligible Age

18 Weeks

Eligible Sex

ALL

Accepts Healthy Volunteers

No