RECRUITING

A Clinical Efficacy and Safety Study of OHB-607 in Preventing Bronchopulmonary Dysplasia in Extremely Premature Infants

Conditions

Bronchopulmonary Dysplasia Chronic Lung Disease of Prematurity Intraventricular Hemorrhage Retinopathy of Prematurity (ROP)

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

The purpose of this study is to determine if an investigational drug can prevent Bronchopulmonary Dysplasia, reducing the burden of chronic lung disease in extremely premature infants, as compared to extremely premature infants receiving standard neonatal care alone.

Official Title

A Phase 2b, Multicenter, Randomized, Open-label, Two-Arm Study to Evaluate the Clinical Efficacy and Safety of OHB-607 Compared to Standard Neonatal Care for the Prevention of Bronchopulmonary Dysplasia, the Most Common Cause of Chronic Lung Disease of Prematurity

Quick Facts

Study Start:2019-05-09

Study Completion:2028-01-21

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT03253263

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:0 Hours to 24 Hours

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:CHILD

Inclusion Criteria	Exclusion Criteria
1. Written informed consents and/or assents must be signed and dated by the participant's parent(s) prior to any study related procedures. The informed consent and any assents for underage parents must be approved by the IRB/IEC (in accordance with local regulations). 2. Written informed consents and/or assents must be signed and dated by the participant's birth mother prior to providing study-related information related to birth mother medical history, pregnancy and the birth of the participant. The informed consent and any assents for underage birth mothers must be approved by the IRB/IEC (in accordance with local regulations). 3. Subjects must be between 23 weeks +0 days and 27 weeks +6 days GA, inclusive.	1. Detectable major (or severe) congenital malformation identified before randomization. 2. Known or suspected chromosomal abnormality, genetic disorder, or syndrome, identified before randomization, according to the investigator's opinion. 3. Hypoglycemia at Baseline (blood glucose less than (\<) 45 milligrams per deciliter \[mg/dL\] or 2.5 milli moles per liter \[mmol/L\]) which persists in spite of glucose supplementation, to exclude severe congenital abnormalities of glucose metabolism. 4. Clinically significant neurological disease identified before randomization according to cranial ultrasound (hemorrhages confined to the germinal matrix are allowed) and investigator's opinion. 5. Any other condition or therapy that, in the investigator's opinion, may pose a risk to the participant or interfere with the participant's potential compliance with this protocol or interfere with interpretation of results. 6. Current or planned participation in a clinical study of another investigational study treatment, device, or procedure (participation in non-interventional studies is permitted on a case-by-case basis). 7. The participant or participant's parent(s) is/are unable to comply with the protocol or is unlikely to be available for long-term follow-up as determined by the investigator. 8. Birth mother with active COVID-19 infection at birth or a history of severe COVID-19 infection (requiring intensive care hospitalization) during pregnancy.

Inclusion Criteria

Exclusion Criteria

1. Written informed consents and/or assents must be signed and dated by the participant's parent(s) prior to any study related procedures. The informed consent and any assents for underage parents must be approved by the IRB/IEC (in accordance with local regulations).
2. Written informed consents and/or assents must be signed and dated by the participant's birth mother prior to providing study-related information related to birth mother medical history, pregnancy and the birth of the participant. The informed consent and any assents for underage birth mothers must be approved by the IRB/IEC (in accordance with local regulations).
3. Subjects must be between 23 weeks +0 days and 27 weeks +6 days GA, inclusive.

1. Detectable major (or severe) congenital malformation identified before randomization.
2. Known or suspected chromosomal abnormality, genetic disorder, or syndrome, identified before randomization, according to the investigator's opinion.
3. Hypoglycemia at Baseline (blood glucose less than (\<) 45 milligrams per deciliter \[mg/dL\] or 2.5 milli moles per liter \[mmol/L\]) which persists in spite of glucose supplementation, to exclude severe congenital abnormalities of glucose metabolism.
4. Clinically significant neurological disease identified before randomization according to cranial ultrasound (hemorrhages confined to the germinal matrix are allowed) and investigator's opinion.
5. Any other condition or therapy that, in the investigator's opinion, may pose a risk to the participant or interfere with the participant's potential compliance with this protocol or interfere with interpretation of results.
6. Current or planned participation in a clinical study of another investigational study treatment, device, or procedure (participation in non-interventional studies is permitted on a case-by-case basis).
7. The participant or participant's parent(s) is/are unable to comply with the protocol or is unlikely to be available for long-term follow-up as determined by the investigator.
8. Birth mother with active COVID-19 infection at birth or a history of severe COVID-19 infection (requiring intensive care hospitalization) during pregnancy.

Contacts and Locations

Study Contact

OHB Contact

CONTACT

CMO@Oakhillbio.com

Study Locations (Sites)

Arkansas Children's Hospital

Little Rock, Arkansas, 72202-3500

United States

University of Arkansas for Medical Sciences

Little Rock, Arkansas, 72202-3500

United States

LAC USC Medical Center

Los Angeles, California, 90033-1804

United States

Jackson Memorial Hospital

Miami, Florida, 33136-1005

United States

Tampa General Hospital

Tampa, Florida, 33606-3571

United States

University of Illinois at Chicago

Chicago, Illinois, 60612

United States

Memorial Hospital of South Bend

South Bend, Indiana, 46601-1078

United States

Ochsner Baptist Medical Center

New Orleans, Louisiana, 70115

United States

Tufts Medical Center

Boston, Massachusetts, 02111-1553

United States

Boston Children's Hospital

Boston, Massachusetts, 02115

United States

University of Mississippi Medical Center

Jackson, Mississippi, 39216-4500

United States

Nationwide Children's Hospital

Columbus, Ohio, 43205

United States

University of Oklahoma Health Sciences Center

Oklahoma City, Oklahoma, 73104

United States

Medical University of South Carolina Children Hospital

Charleston, South Carolina, 29425-8908

United States

Virginia Commonwealth University - Children's Hospital of Richmond at VCU

Richmond, Virginia, 23298-5075

United States

Collaborators and Investigators

Sponsor: OHB Neonatology Ltd.

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2019-05-09

Study Completion Date2028-01-21

Study Record Updates

Study Start Date2019-05-09

Study Completion Date2028-01-21

Terms related to this study

Additional Relevant MeSH Terms

Bronchopulmonary Dysplasia
Chronic Lung Disease of Prematurity
Intraventricular Hemorrhage
Retinopathy of Prematurity (ROP)