Arterial Oxygen Saturation on Ventilatory Stability in Extremely Premature Infants

University of Miami

Status: Completed

Conditions: Periodic Breathing; Central Apnea; Desaturation of Blood; Apnea of Prematurity; Obstructive Apnea of Newborn

Treatments: Other: Targeting SpO2 at 93-95%; Other: Targeting SpO2 at 90-92%

Study type: Interventional

Funder types: Other

Identifiers

NCT03695900

20180536

Details and patient eligibility

About

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).

Enrollment: 19 patients

Sex: All

Ages: Under 18 weeks old

Volunteers: No 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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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19 participants in 2 patient groups

Targeting SpO2 at 93-95% followed by targeting at 90-92%

Other group

Description:

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.

Treatment:

Other: Targeting SpO2 at 93-95%

Other: Targeting SpO2 at 90-92%

Targeting SpO2 at 90-92% followed by targeting at 93-95%

Other group

Description:

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.

Treatment:

Other: Targeting SpO2 at 93-95%

Other: Targeting SpO2 at 90-92%