Clinical trial NCT01220687: Inhaled Nitric Oxide (iNO) as an Adjunct to Neonatal Resuscitation
Official title: Administration of Inhaled Nitric Oxide (iNO) as an Adjunct to Neonatal Resuscitation Protocol: A Pilot Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Respiratory Distress Syndrome in Premature Infants
Very Low Birth Weight Baby
Keywords: Prematurity
Oxygen exposure
Nitric Oxide
Lead sponsor: University of Oklahoma
Sponsor class: OTHER
Collaborators: name: Mallinckrodt
First posted: 2010-10-14
Enrollment: 33
Sex: ALL
Minimum age (years): 1
Maximum age (years): 2
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* Infants that are 25 0/7 - 31 6/7 weeks gestation
* Infants who require Continuous Positive Airway Pressure (CPAP) or Positive Pressure Ventilation ( 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

Primary outcomes:
measure: Maximum Factional Inspired Oxygen Percent (FiO2)
timeFrame: 20 minutes
measure: Rate of Hyperoxia
timeFrame: 20 minutes
measure: Pre and Postductal Saturation Levels
timeFrame: at 20 minutes (end of study)
measure: Heart Rate During Resuscitation
timeFrame: 5, 10 and 20 minutes on study
measure: Need for Intubation
timeFrame: by end of study, 20 minutes
Secondary outcomes:
measure: Intraventricular Hemorrhage > Grade 2
timeFrame: Hospital Discharge
measure: Infants With Patent Ductus Arteriosus (PDA) Requiring Treatment
timeFrame: Prior to infant discharge from the hospital
measure: Retinopathy of Prematurity (ROP)> Stage 2
timeFrame: Prior to infant discharge from the hospital
measure: Mechanical Ventilation, Non-invasive Ventilation (NIV), and Length of Stay in Days (LOS)
timeFrame: Prior to infant discharge from the hospital
measure: Bronchopulmonary Dysplasia
timeFrame: at 36 weeks adjusted gestational age of participant
measure: Late Onset Sepsis
timeFrame: at any time during study period
Other outcomes:
Locations:
city: Oklahoma City
country: United States
facility: University of Oklahoma Health Sciences Center
state: Oklahoma
city: Oklahoma City
country: United States
facility: University of Oklahoma, Childrens Hospital
state: Oklahoma
Study officials:
affiliation: University of Oklahoma
name: Kris Sekar, M.D.
role: PRINCIPAL_INVESTIGATOR
References: