Inhaled Nitric Oxide (iNO) as an Adjunct to Neonatal Resuscitation

University of Oklahoma (OU)

Status: Completed

Conditions: Respiratory Distress Syndrome in Premature Infants; Very Low Birth Weight Baby

Treatments: Drug: iNO; Other: Nitrogen

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01220687

1976

Details and patient eligibility

About

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.

Full 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.

Enrollment: 33 patients

Sex: All

Ages: 1 to 2 minutes old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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33 participants in 2 patient groups, including a placebo group

Placebo 20ppm

Placebo Comparator group

Description:

Nitrogen at 20 ppm at the beginning of study start with gradual taper at 10 minutes of the study and completely off by 17 minutes of the study

Treatment:

Other: Nitrogen

Inhaled Nitric Oxide (iNO) 20 ppm

Experimental group

Description:

Inhaled Nitric Oxide 20 ppm at the beginning of study start with gradual taper at 10 minutes of the study and completely off by 17 minutes of the study

Treatment:

Drug: iNO