Skip to main content
OpenTrials
Completed

NCT Number: NCT03695900

Arterial Oxygen Saturation 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).

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Apnea of Prematurity Apnea Central Apnea Desaturation of Blood Dyssomnias Nervous System Diseases Obstructive Apnea of Newborn Pathological Conditions, Signs and Symptoms Periodic Breathing Respiration Disorders Respiratory Tract Diseases Signs and Symptoms Signs and Symptoms, Respiratory Sleep Apnea Syndromes Sleep Apnea, Central Sleep Disorders, Intrinsic Sleep Wake Disorders

Age range

Up to 18 week

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Holtz Children's Hospital

Miami, Florida, 33136, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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%

Other

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

Primary outcomes

  1. ventilatory stability by frequency of central apnea

    Time frame: 2 hours

    by frequency of central apnea

  2. ventilatory stability by frequency of obstructive apnea

    Time frame: 2 hours

    by frequency of obstructive apnea

  3. ventilatory stability by density of periodic breathing

    Time frame: 2 hours

    by density of periodic breathing

  4. ventilatory stability by time series of inter-breath intervals

    Time frame: 2 hours

    by time series of inter-breath intervals

Secondary outcomes

  1. oxygenation stability by frequency of intermittent hypoxemia episodes

    Time frame: 2 hours

    frequency of episodes with SpO2 < 80%

  2. frequency of bradycardia episodes

    Time frame: 2 hours

    frequency of episodes with HR < 100 bpm

Sponsors and collaborators

Lead sponsor

University of Miami

Other

Collaborators

  • The Gerber Foundation

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Oct 4, 2018
Registry last updated
May 10, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.