Inhaled Nitric Oxide (iNO) as an Adjunct to Neonatal Resuscitation
Condition: Respiratory Distress Syndrome in Premature Infants; Very Low Birth Weight Baby
MeSH terms: Respiratory Distress Syndrome; Respiratory Distress Syndrome, Newborn; Birth Weight
Study type: Interventional

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.
    

Intervention name(s): iNO; Nitrogen
Intervention type(s): Drug; Other
Intervention description(s): Immediately after birth, subjects will be randomized to receive iNO (20ppm) or nitrogen (placebo gas) with blended oxygen (starting with 0.3). Fraction of inspired oxygen 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.; Subjects will be randomized to receive iNO (20ppm) or nitrogen (placebo gas) with blended oxygen (starting with 0.3). Fraction of inspired oxygen 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 intervention name(s): Inhaled Nitric Oxide
Intervention MeSH terms: Nitric Oxide
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Prematurity; Oxygen exposure; Nitric Oxide