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Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from 6 months ca through 24 months ca
Awards & highlights
Study Summary
This trial will test if an experimental drug can help improve lung function in premature babies.
Who is the study for?
This trial is for extremely premature infants born between 23 and 27 weeks of gestation. Parents must consent to the study, which excludes infants with significant neurological disease, major congenital malformations, genetic disorders, or those whose mothers had severe COVID-19 during pregnancy.Check my eligibility
What is being tested?
The study tests OHB-607's effectiveness in preventing chronic lung disease in extremely premature babies compared to standard care alone. It aims to see if this drug can reduce long-term respiratory issues these infants often face.See study design
What are the potential side effects?
Potential side effects are not specified here but would typically include reactions expected from introducing a new medication into an infant's system such as digestive disturbances or allergic reactions.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ from 6 months ca through 24 months ca
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from 6 months ca through 24 months ca
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Reduction in the incidence of severe Bronchopulmonary Dysplasia (BPD) at 36 weeks (±3 days) Postmenstrual Age (PMA), or death at or before 36 weeks PMA, whichever comes first as compared to the SNC group.
Secondary outcome measures
Chronic respiratory morbidity outcomes at 24 months CA
Exposure-response relationship between measured IGF-1 and Bronchopulmonary Dysplasia (BPD)
Exposure-response relationship between measured IGF-1 and Retinopathy of Prematurity (ROP)
+15 moreSide effects data
From 2008 Phase 3 trial • 137 Patients • NCT0012516424%
Upper respiratory tract infection
16%
Headache
16%
Cough
12%
Sinusitis
12%
Otitis media
8%
Ear pain
8%
Pharyngitis streptococcal
8%
Nasopharyngitis
4%
Pain in extremity
4%
Cellulitis
4%
Hypoglycemia
4%
Influenza
100%
80%
60%
40%
20%
0%
Study treatment Arm
Untreated
40 μg/kg BID (Twice Daily Dosing)
80 μg/kg BID (Twice Daily Dosing)
120 μg/kg BID (Twice Daily Dosing)
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: OHB-607Experimental Treatment1 Intervention
Participants will receive continuous IV infusion of OHB-607 through from birth up to PMA 29 weeks +6 days.
Group II: Standard Neonatal CareActive Control1 Intervention
Standard neonatal care alone will be provided.
Research Highlights
Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
The most common treatments for Bronchopulmonary Dysplasia (BPD) include corticosteroids and surfactant therapy. Corticosteroids work by reducing inflammation in the lungs, which is critical for improving lung function and reducing the need for mechanical ventilation.
Surfactant therapy helps to keep the airways open by reducing surface tension, which is essential for preventing lung collapse and improving oxygenation. The investigational drug being studied aims to prevent BPD by potentially reducing inflammation or promoting lung development, which is vital for minimizing lung damage and improving long-term respiratory outcomes in extremely premature infants.
Effect of early low-dose hydrocortisone on survival without bronchopulmonary dysplasia in extremely preterm infants (PREMILOC): a double-blind, placebo-controlled, multicentre, randomised trial.
Effect of early low-dose hydrocortisone on survival without bronchopulmonary dysplasia in extremely preterm infants (PREMILOC): a double-blind, placebo-controlled, multicentre, randomised trial.
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Who is running the clinical trial?
ShireLead Sponsor
456 Previous Clinical Trials
96,954 Total Patients Enrolled
1 Trials studying Bronchopulmonary Dysplasia
26 Patients Enrolled for Bronchopulmonary Dysplasia
OHB Neonatology Ltd.Lead Sponsor
Oak Hill Bio LtdLead Sponsor
1 Previous Clinical Trials
26 Total Patients Enrolled
1 Trials studying Bronchopulmonary Dysplasia
26 Patients Enrolled for Bronchopulmonary Dysplasia
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I have a genetic condition identified by my doctor.My blood sugar is very low even after taking glucose.You have a serious neurological disease that was found before the study starts, and it's confirmed by a brain ultrasound and the doctor's opinion.The mother had COVID-19 when the baby was born or had a serious case of COVID-19 while pregnant.Participants must be between 23 weeks and 27 weeks of pregnancy.
Research Study Groups:
This trial has the following groups:- Group 1: OHB-607
- Group 2: Standard Neonatal Care
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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