Inhaled Nitric Oxide (iNO) as an Adjunct to Neonatal Resuscitation
| Status: | Completed |
|---|---|
| Conditions: | Hospital, Women's Studies |
| Therapuetic Areas: | Other, Reproductive |
| Healthy: | No |
| Age Range: | Any |
| Updated: | 1/7/2018 |
| Start Date: | April 2011 |
| End Date: | May 1, 2017 |
Administration of Inhaled Nitric Oxide (iNO) as an Adjunct to Neonatal Resuscitation Protocol: A Pilot Trial
This study hopes to determine whether nitric oxide along with oxygen during the first 20
minutes of life in infants needing help with breathing will reduce the percentage and total
exposure to oxygen during that time frame. Although the use of oxygen in management of
breathing is an important part of supporting baby immediately after delivery, there is more
evidence that too much exposure to oxygen may lead to potential problems for your baby later.
Oxygen exposure can be harmful to premature babies developing lungs.
minutes of life in infants needing help with breathing will reduce the percentage and total
exposure to oxygen during that time frame. Although the use of oxygen in management of
breathing is an important part of supporting baby immediately after delivery, there is more
evidence that too much exposure to oxygen may lead to potential problems for your baby later.
Oxygen exposure can be harmful to premature babies developing lungs.
Current Neonatal Resuscitation Program (NRP) guidelines suggest the use of supplemental
oxygen up to fraction of inspired oxygen of 1.0 during neonatal resuscitation for both term
and preterm newborns. Exposure to supplemental oxygen in preterm babies has been shown to
have significant toxicity. Even minimal exposure in the first hours of life has been shown to
be associated with morbidity including later onset of cancer. The transition from fetal
circulation to neonatal circulation is a complex process requiring lung inflation and
decrease in pulmonary vascular resistance. Endogenous nitric oxide, along with oxygen, plays
a major role in facilitating this transition by decreasing pulmonary vascular resistance. It
is not known whether exogenous nitric oxide would facilitate this transition. In this study,
we propose a novel approach to resuscitation of preterm infants where inhaled nitric oxide
(iNO) will be used as an adjunct to oxygen with the primary goal of reducing supplemental
oxygen exposure. This study is designed to be a double-blind, randomized, -placebo-
controlled pilot trial with strict monitoring of parameters during transition in the delivery
room.
oxygen up to fraction of inspired oxygen of 1.0 during neonatal resuscitation for both term
and preterm newborns. Exposure to supplemental oxygen in preterm babies has been shown to
have significant toxicity. Even minimal exposure in the first hours of life has been shown to
be associated with morbidity including later onset of cancer. The transition from fetal
circulation to neonatal circulation is a complex process requiring lung inflation and
decrease in pulmonary vascular resistance. Endogenous nitric oxide, along with oxygen, plays
a major role in facilitating this transition by decreasing pulmonary vascular resistance. It
is not known whether exogenous nitric oxide would facilitate this transition. In this study,
we propose a novel approach to resuscitation of preterm infants where inhaled nitric oxide
(iNO) will be used as an adjunct to oxygen with the primary goal of reducing supplemental
oxygen exposure. This study is designed to be a double-blind, randomized, -placebo-
controlled pilot trial with strict monitoring of parameters during transition in the delivery
room.
Inclusion Criteria:
- Infants that are 25 0/7 - 31 6/7 weeks gestation
- Infants who require CPAP or PPV during delivery room resuscitation.
Exclusion Criteria:
- Refusal of consent
- Known complex congenital anomalies of the heart or lungs
- Known major genetic defects
- Hydrops fetalis
We found this trial at
2
sites
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940 NE 13th St
Oklahoma City, Oklahoma 73190
Oklahoma City, Oklahoma 73190
(405) 271-6458
Principal Investigator: Kris Sekar, M.D.
Phone: 405-271-5215
University of Oklahoma Health Sciences Center The OU Health Sciences Center is composed of seven...
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