Arterial Oxygen Saturation on Ventilatory Stability in Extremely Premature Infants

Apnea of Prematurity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03695900
• Other study ID #: 20180536
• Status: Completed
• Phase: N/A
• Start date: November 1, 2018
• Est. completion date: November 8, 2019

Study information

• Verified date: May 2023
• Source: University of Miami
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 19
• Est. completion date: November 8, 2019
• Est. primary completion date: November 8, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 18 Weeks

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

Other:
• Targeting SpO2 at 93-95%
FiO2 adjusted to keep basal SpO2 at target range of 93-95% for 2 hours
• Targeting SpO2 at 90-92%
FiO2 adjusted to keep basal SpO2 at target range of 90-92% for 2 hours.

Locations

Country	Name	City	State
United States	Holtz Children's Hospital	Miami	Florida

Sponsors (2)

Lead Sponsor	Collaborator
University of Miami	The Gerber Foundation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	ventilatory stability by frequency of central apnea	by frequency of central apnea	2 hours
Primary	ventilatory stability by frequency of obstructive apnea	by frequency of obstructive apnea	2 hours
Primary	ventilatory stability by density of periodic breathing	by density of periodic breathing	2 hours
Primary	ventilatory stability by time series of inter-breath intervals	by time series of inter-breath intervals	2 hours
Secondary	oxygenation stability by frequency of intermittent hypoxemia episodes	frequency of episodes with SpO2 < 80%	2 hours
Secondary	frequency of bradycardia episodes	frequency of episodes with HR < 100 bpm	2 hours