Arterial Oxygen Saturation on Ventilatory Stability in Extremely Premature Infants

Study Overview
=================
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).

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

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

Intervention / Treatment
-----------------
* Other: Targeting SpO2 at 93-95%
* Other: Targeting SpO2 at 90-92%


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Maximum Age: 18 Weeks

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Crossover Assignment
Interventional 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.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Targeting SpO2 at 93-95% followed by targeting at 90-92%<br>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. | Other: Targeting SpO2 at 93-95%<br>* FiO2 adjusted to keep basal SpO2 at target range of 93-95% for 2 hours<br>Other: Targeting SpO2 at 90-92%<br>* FiO2 adjusted to keep basal SpO2 at target range of 90-92% for 2 hours.<br>|
| Other: Targeting SpO2 at 90-92% followed by targeting at 93-95%<br>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. | Other: Targeting SpO2 at 93-95%<br>* FiO2 adjusted to keep basal SpO2 at target range of 93-95% for 2 hours<br>Other: Targeting SpO2 at 90-92%<br>* FiO2 adjusted to keep basal SpO2 at target range of 90-92% for 2 hours.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| ventilatory stability by frequency of central apnea | by frequency of central apnea | 2 hours | 
| ventilatory stability by frequency of obstructive apnea | by frequency of obstructive apnea | 2 hours | 
| ventilatory stability by density of periodic breathing | by density of periodic breathing | 2 hours | 
| ventilatory stability by time series of inter-breath intervals | by time series of inter-breath intervals | 2 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| oxygenation stability by frequency of intermittent hypoxemia episodes | frequency of episodes with SpO2 < 80% | 2 hours | 
| frequency of bradycardia episodes | frequency of episodes with HR < 100 bpm | 2 hours |