Oxygenation Instability and Maturation of Control of Breathing in Premature Infants



Status:Recruiting
Conditions:Women's Studies
Therapuetic Areas:Reproductive
Healthy:No
Age Range:Any
Updated:9/7/2018
Start Date:September 4, 2018
End Date:August 2021
Contact:Carmen D'Ugard
Email:cdugard@med.miami.edu
Phone:3055856404

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Premature infants present with significant oxygenation instability in the form of frequent
spontaneous episodes of hypoxemia during the first weeks after birth. These infants are also
exposed to hyperoxemia.

The objective of this study is to determine the extent to which exposure to frequent episodes
of hypoxemia and hyperoxemia in extreme premature infants during the early stages of their
evolving lung disease is associated with altered maturation and function of their respiratory
control system.

This study is part of the Prematurity-Related Ventilatory Control (Pre-Vent): Role in
Respiratory Outcomes Clinical Research Centers (CRC) (U01) cooperative program of the
National Heart Lung and Blood Institute (NHLBI) of the National Institutes of Health (NIH).

Most extreme premature infants present with respiratory failure due to altered lung function
compounded by breathing instability due to an immature respiratory control function.

Premature infants present with significant oxygenation instability in the form of frequent
spontaneous episodes of hypoxemia during the first weeks after birth. As a result, these
infants receive oxygen supplementation but this is often excessive and these infants are also
exposed to hyperoxemia. The extent to which these episodes of hypoxemia or the exposure to
hyperoxemia impact on the maturation and function of the control of breathing system in
extreme premature infants during the evolving stages of their respiratory disease is unknown.
This is a prospective study that will systematically evaluate such association in extreme
premature infants.

The main objective of this study is to determine the extent to which exposure to frequent
episodes of hypoxemia and hyperoxemia in extreme premature infants during the early stages of
their evolving lung disease is associated with altered maturation and function of their
respiratory control system.

This study is part of the Prematurity-Related Ventilatory Control (Pre-Vent): Role in
Respiratory Outcomes Clinical Research Centers (CRC) (U01) cooperative program of the
National Heart Lung and Blood Institute (NHLBI) of the National Institutes of Health (NIH).

Inclusion Criteria:

- Premature infants born at 23 0/7- 28 6/7 weeks gestational age

- Postnatal age up to 28 days

- Requiring supplemental oxygen and/or receiving mechanical ventilation, CPAP, nasal
ventilation or nasal cannula

Exclusion Criteria:

- Severe congenital anomalies that may affect life expectancy or pulmonary or
neurosensory development

- Severe CNS pathology that may alter respiratory control function
We found this trial at
1
site
1611 Northwest 12th Avenue
Miami, Florida 33136
Phone: 305-585-6404
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Miami, FL
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