Inhaled Prostaglandin E1 (IPGE1) for Hypoxemic Respiratory Failure (NHRF)

NCT01467076 | Terminated Phase 2 Results DMC

• 13 other identifiers: NICHD-NRN-0046U10HD040689U10HD021385U10HD027904U10HD027880U10HD034216U10HD040492U10HD053109U10HD040461U10HD068263U10HD068270U10HD068278U10HD036790
• Study Type: interventional
• Target: 7
• Locations: 1 country
• Sites: 11

Brief Summary

This is a randomized controlled trial (RCT) on the use of Inhaled prostaglandin E1 (IPGE1) in Neonatal Hypoxemic Respiratory Failure (NHRF). Fifty patients recruited at 10 high volume sites within the NICHD Neonatal Research Network will constitute a pilot sample to evaluate the feasibility and safety of prolonged IPGE1 administration and determination of optimal dose. In this Pilot RCT, two doses of IPGE1 (300 and 150 ng/kg/min) will be administered over a maximum duration of 72 hours and compared with placebo. Once feasibility and safety of IPGE1 administered over 72 hours has been demonstrated in the pilot trial, a full scale randomized controlled trial will be planned.

Conditions

Prematurity; Respiratory Insufficiency; Pulmonary Hypertension; Respiratory Distress Syndrome, Newborn

Outcome Measures

Primary Outcomes (1)

• Feasibility Assessed as the Number of Participants Who Were Enrolled in the Study

  The primary outcome is the ability to recruit adequate number of infants (n=50) in a 9 month period without excessive (\>20%) protocol violations.

  From study start through 9 months after 75% of the participating sites are enrolling

Secondary Outcomes (9)

• Change in Partial Pressure of Oxygen in the Blood (PaO2)

  Measurement of ABG at 60±15 minutes and 4±2 hours after start of study aerosol.

• Change in Oxygenation Index (OI)

  Measurement of ABG at 60±15 minutes and 4±2 hours after start of study aerosol.

• Need for Inhaled Nitric Oxide (INO) 72 Hours After INO

  Date of first administration of INO to date of final discontinuation of INO

• Duration of iNO Therapy

  From date of first administration of INO to date of final discontinuation of INO.

• Death

  From birth through status (death, transfer, or discharge).

Study Arms (3)

Inhaled PGE1 (150 ng/kg/min)

ACTIVE COMPARATOR

150 ng/kg/min Inhaled PGE1

Drug: Inhaled PGE1

Aerosolized Normal Saline

PLACEBO COMPARATOR

Eligible infants will be randomly assigned to either IPGE1 \[150ng/kg/min\], IPGE1 \[300ng/kg/min\] or control group. Infants in the control group will receive the same volume of aerosolized saline and oxygen from the respirator.

Drug: Aerosolized Normal Saline

Inhaled PGE1 (300 ng/kg/min)

ACTIVE COMPARATOR

300 ng/kg/min of Inhaled PGE1

Drug: Inhaled PGE1

Interventions

Aerosolized Normal Saline DRUG

Two initial doses of IPGE1 will be tested - 150 and 300 ng/kg/min. Thus, there will be three arms to the study - IPGE1 \[150\], IPGE1 \[300\], and placebo (normal saline). This design will allow comparison of the two doses of IPGE1 with each other and controls; and also allow comparison of any IPGE1 with controls. Placebo will be administered over a maximum duration of 72 hours.

Also known as: Normal Saline

Aerosolized Normal Saline

Inhaled PGE1 DRUG

Two initial doses of IPGE1 will be tested - 150 and 300 ng/kg/min. Thus, there will be three arms to the study - IPGE1 \[150\], IPGE1 \[300\], and placebo (normal saline). This design will allow comparison of the two doses of IPGE1 with each other and controls; and also allow comparison of any IPGE1 with controls. In this Pilot RCT, two doses of IPGE1 (300 and 150 ng/kg/min) will be administered over a maximum duration of 72 hours to determine the optimal dose and duration of therapy.

Also known as: Inhaled Prostaglandin E1

Inhaled PGE1 (150 ng/kg/min); Inhaled PGE1 (300 ng/kg/min)

Eligibility Criteria

• Age: Up to 7 Days
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Gestational age less than or equal to 34 weeks
• Postnatal age less than or equal to 7 days (168 hours).
• Assisted ventilation for hypoxemic respiratory failure.
• Diagnosis of NHRF including perinatal aspiration syndrome (meconium, blood, or amniotic fluid), suspected/proven pneumonia/sepsis, respiratory distress syndrome, idiopathic persistent pulmonary hypertension of the newborn (PPHN) or suspected pulmonary hypoplasia.
• Receiving INO for at least 1 hour and not \>72 hours.
• Oxygenation Index (OI ) ≥ 15 on any 2 arterial blood gases 15 minutes to 12 hours apart while on INO.
• An indwelling arterial line is present

You may not qualify if:

• Any infant in whom a decision has been made not to provide full treatment (e.g. chromosomal anomalies, severe birth asphyxia).
• Known structural congenital heart disease except patent ductus arteriosus and atrial/ventricular level shunts.
• Congenital diaphragmatic hernia.
• Thrombocytopenia unresponsive to platelet transfusion.
• Enrollment in a conflicting and/or Investigational New Drug (IND) clinical trial.

Sponsors & Collaborators

• NICHD Neonatal Research Network: lead
• National Center for Research Resources (NCRR): collaborator
• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD): collaborator

Study Sites (11)

University of Alabama at Birmingham

Birmingham, Alabama, 35233, United States

Location

University of California - Los Angeles

Los Angeles, California, 90025, United States

Location

Stanford University

Palo Alto, California, 94304, United States

Location

University of Iowa

Iowa City, Iowa, 52242, United States

Location

Wayne State University

Detroit, Michigan, 48201, United States

Location

University of New Mexico

Albuquerque, New Mexico, 87131, United States

Location

University of Rochester

Rochester, New York, 14642, United States

Location

Duke University

Durham, North Carolina, 27710, United States

Location

Research Institute at Nationwide Children's Hospital

Columbus, Ohio, 43205, United States

Location

Brown University, Women & Infants Hospital of Rhode Island

Providence, Rhode Island, 02905, United States

Location

University of Texas Southwestern Medical Center at Dallas

Dallas, Texas, 75235, United States

Location

Related Publications (1)

• Sood BG, Keszler M, Garg M, Klein JM, Ohls R, Ambalavanan N, Cotten CM, Malian M, Sanchez PJ, Lakshminrusimha S, Nelin LD, Van Meurs KP, Bara R, Saha S, Das A, Wallace D, Higgins RD, Shankaran S; Eunice Kennedy Shriver National Institute of Child Health and Human Development Neonatal Research Network. Inhaled PGE1 in neonates with hypoxemic respiratory failure: two pilot feasibility randomized clinical trials. Trials. 2014 Dec 12;15:486. doi: 10.1186/1745-6215-15-486.

  PMID: 25496504 DERIVED

Related Links

• Neonatal Research Network

MeSH Terms

Conditions

Premature Birth; Respiratory Insufficiency; Hypertension, Pulmonary; Respiratory Distress Syndrome, Newborn

Interventions

Saline Solution

Condition Hierarchy (Ancestors)

Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Respiration Disorders; Respiratory Tract Diseases; Lung Diseases; Hypertension; Vascular Diseases; Cardiovascular Diseases; Respiratory Distress Syndrome; Infant, Premature, Diseases; Infant, Newborn, Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Results Point of Contact

• Title: Beena Sood, M.D.
• Organization: Wayne State University

bsood@med.wayne.edu

313-745-5638

Study Officials

• Beena Sood, MD

  Wayne State University

  PRINCIPAL INVESTIGATOR

• Martin Keszler, MD

  Brown University, Women & Infants Hospital of Rhode Island

  PRINCIPAL INVESTIGATOR

• C. Michael Cotten, MD

  Duke University

  PRINCIPAL INVESTIGATOR

• Abhik Das, PhD

  RTI International

  PRINCIPAL INVESTIGATOR

• Krisa P Van Meurs, MD

  Stanford University

  PRINCIPAL INVESTIGATOR

• Namasivayam Ambalavanan, MD

  University of Alabama at Birmingham

  PRINCIPAL INVESTIGATOR

• Jonathan M Klein, MD

  University of Iowa

  PRINCIPAL INVESTIGATOR

• Robin Ohls, MD

  University of New Mexico

  PRINCIPAL INVESTIGATOR

• Pablo J Sanchez, MD

  University of Texas, Southwestern Medical Center at Dallas

  PRINCIPAL INVESTIGATOR

• Satyan Lakshminrusimha, MD

  University of Rochester

  PRINCIPAL INVESTIGATOR

• Uday Devaskar, MD

  University of California, Los Angeles

  PRINCIPAL INVESTIGATOR

• Leif Nelin, MD

  Research Institute at Nationwide Children's Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 17, 2011
• First Posted: November 8, 2011
• Study Start: November 1, 2011
• Primary Completion: May 1, 2012
• Study Completion: June 1, 2012
• Last Updated: April 24, 2019
• Results First Posted: December 30, 2016

Record last verified: 2019-04

Locations

US (11)