Arterial Oxygen Saturation on Ventilatory Stability in Extremely Premature Infants

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03695900

Enrollment

Registered

2018-10-04

Start date

2018-11-01

Completion date

2019-11-08

Last updated

2023-05-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

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).

Interventions

OTHERTargeting SpO2 at 93-95%

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

OTHERTargeting SpO2 at 90-92%

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

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

OTHER

Masking

NONE

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.

Eligibility

Sex/Gender

ALL

Age

No minimum to 18 Weeks

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
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 density of periodic breathing	2 hours	by density of periodic breathing
ventilatory stability by time series of inter-breath intervals	2 hours	by time series of inter-breath intervals

Secondary

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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026