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

NCT01220687 | Completed Results DMC

• 1 other identifier: 1976
• Study Type: interventional
• Target: 33
• Locations: 1 country
• Sites: 2

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.

Conditions

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

Keywords

Prematurity; Oxygen exposure; Nitric Oxide

Outcome Measures

Primary Outcomes (5)

• Maximum Factional Inspired Oxygen Percent (FiO2)

  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 Neonatal Resuscitation Program (NRP) protocol.

  20 minutes

• Rate of Hyperoxia

  FiO2 \>60% at any 5 second increment during the study period of 20 minutes for each infant in each arm.

  20 minutes

• Pre and Postductal Saturation Levels

  Oxygen saturations as described as preductal (right hand) as well as post ductal (either foot) and measured as percent of saturated hemoglobin by pulse oximetry.

  at 20 minutes (end of study)

• Heart Rate During Resuscitation

  Measured and recorded heart rates every 5 seconds on study as described as beats per minute (BPM)

  5, 10 and 20 minutes on study

• Need for Intubation

  Infants requiring placement of endotracheal tube as part of the Neonatal Resuscitation Program algorithm for airway management.

  by end of study, 20 minutes

Secondary Outcomes (6)

• Intraventricular Hemorrhage > Grade 2

  Hospital Discharge

• Infants With Patent Ductus Arteriosus (PDA) Requiring Treatment

  Prior to infant discharge from the hospital

• Retinopathy of Prematurity (ROP)> Stage 2

  Prior to infant discharge from the hospital

• Mechanical Ventilation, Non-invasive Ventilation (NIV), and Length of Stay in Days (LOS)

  Prior to infant discharge from the hospital

• Bronchopulmonary Dysplasia

  at 36 weeks adjusted gestational age of participant

Study Arms (2)

Placebo 20ppm

PLACEBO COMPARATOR

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

Other: Nitrogen

Inhaled Nitric Oxide (iNO) 20 ppm

EXPERIMENTAL

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

Drug: iNO

Interventions

iNO DRUG

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.

Also known as: Inhaled Nitric Oxide

Inhaled Nitric Oxide (iNO) 20 ppm

Nitrogen OTHER

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.

Placebo 20ppm

Eligibility Criteria

• Age: 1 Minute - 2 Minutes
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• Refusal of consent
• Known complex congenital anomalies of the heart or lungs
• Known major genetic defects
• Hydrops fetalis

Sponsors & Collaborators

• University of Oklahoma: lead
• Mallinckrodt: collaborator

Study Sites (2)

University of Oklahoma Health Sciences Center

Oklahoma City, Oklahoma, 73104, United States

Location

University of Oklahoma, Childrens Hospital

Oklahoma City, Oklahoma, 73104, United States

Location

MeSH Terms

Conditions

Respiratory Distress Syndrome In Premature Infants; Premature Birth

Interventions

Nitrogen

Condition Hierarchy (Ancestors)

Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Intervention Hierarchy (Ancestors)

Elements; Inorganic Chemicals; Gases

Limitations and Caveats

Small sample size. Recruitment was terminated before reaching our initial target sample size due to precipitous and emergent deliveries, unavailability of the team or baby ineligible due to gestational age at birth.

Results Point of Contact

• Title: Krishnamurhty Sekar, MD, Professor of Pediatrics
• Organization: OUHSC College of Medicine, Pediatrics, Neonatal-Perinatal Medicine

kris-sekar@ouhsc.edu

405-271-5215

Study Officials

• Kris Sekar, M.D.

  University of Oklahoma

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 7, 2010
• First Posted: October 14, 2010
• Study Start: April 1, 2011
• Primary Completion: January 1, 2017
• Study Completion: May 1, 2017
• Last Updated: August 19, 2020
• Results First Posted: August 19, 2020

Record last verified: 2020-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)