Inhaled Nitric Oxide (iNO) as an Adjunct to Neonatal Resuscitation
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Prematurity Low Birth Weight |
Drug: Inhaled Nitric Oxide Other: Nitrogen |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Prevention |
| Official Title: | Administration of Inhaled Nitric Oxide (iNO) as an Adjunct to Neonatal Resuscitation Protocol: A Pilot Trial |
- To investigate whether iNO decreases the supplemental oxygen exposure in the preterm infants who require continuous positive airway pressure (CPAP) or positive pressure ventilation (PPV) during resuscitation as per NRP protocol. [ Time Frame: 20 minutes ] [ Designated as safety issue: No ]
- To determine HR, RR, O2 saturation, cerebral O2 extraction, need for intubation and PPV in the first 20 min of life; to investigate potential impact of resuscitation with iNO on hemodynamics within the first 72 hours of life. [ Time Frame: 72 hours ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 40 |
| Study Start Date: | April 2011 |
| Estimated Study Completion Date: | November 2012 |
| Estimated Primary Completion Date: | November 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Placebo Comparator: Placebo |
Other: Nitrogen
Subjects will be randomized to receive iNO (20ppm) or nitrogen (placebo gas) with blended oxygen (starting with 0.3). FiO2 will be adjusted by 0.1 increments every 15 seconds targeting pre-ductal oxygen saturation of 70-85% in the first 2 minutes of life, and then 85-93% until the end of the study period while requiring supplemental oxygen.
|
| Placebo Comparator: iNO |
Drug: Inhaled Nitric Oxide
Immediately after birth, subjects will be randomized to receive iNO (20ppm) or nitrogen (placebo gas) with blended oxygen (starting with 0.3). FiO2 will be adjusted by 0.1 increments every 15 seconds targeting pre-ductal oxygen saturation of 70-85% in the first 2 minutes of life, and then 85-93% until the end of the study period while requiring supplemental oxygen.
Other Name: Nitrogen
|
Detailed Description:
Current Neonatal Resuscitation Program (NRP) guidelines suggest the use of supplemental oxygen up to FiO2 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.
Eligibility| Ages Eligible for Study: | up to 2 Minutes |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations| Contact: Kris Sekar, M.D. | 405-271-5215 | kris-sekar@ouhsc.edu |
| Contact: Michael McCoy, MS | 405-271-5215 | michael-mccoy@ouhsc.edu |
| United States, Oklahoma | |
| University of Oklahoma Health Sciences Center | Recruiting |
| Oklahoma City, Oklahoma, United States, 73104 | |
| Contact: Kris Sekar, M.D. 405-271-5215 kris-sekar@ouhsc.edu | |
| Contact: Michael McCoy, M.S. 405-271-5215 mike-mccoy@ouhsc.edu | |
| Principal Investigator: Kris Sekar, M.D. | |
| Principal Investigator: | Kris Sekar, M.D. | University of Oklahoma |
More Information
No publications provided
| Responsible Party: | Kris Sekar, Sponsored Program Coordinator, University of Oklahoma |
| ClinicalTrials.gov Identifier: | NCT01220687 History of Changes |
| Other Study ID Numbers: | 15503 |
| Study First Received: | October 7, 2010 |
| Last Updated: | April 11, 2012 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by University of Oklahoma:
|
Prematurity Oxygen exposure Nitric Oxide |
Additional relevant MeSH terms:
|
Birth Weight Body Weight Signs and Symptoms Nitric Oxide Bronchodilator Agents Autonomic Agents Peripheral Nervous System Agents Physiological Effects of Drugs Pharmacologic Actions Anti-Asthmatic Agents |
Respiratory System Agents Therapeutic Uses Free Radical Scavengers Antioxidants Molecular Mechanisms of Pharmacological Action Neurotransmitter Agents Endothelium-Dependent Relaxing Factors Vasodilator Agents Cardiovascular Agents Protective Agents |
ClinicalTrials.gov processed this record on May 23, 2013