What side effects are associated with this type of intervention?

Common treatments for Bronchopulmonary Dysplasia (BPD) include oxygen therapy, mechanical ventilation, corticosteroids, and diuretics. Oxygen therapy and mechanical ventilation can lead to lung injury and infections. Corticosteroids, while reducing inflammation, can cause side effects such as hypertension, hyperglycemia, and growth retardation. Diuretics may lead to electrolyte imbalances and dehydration. Investigational drugs, like the one being studied for BPD prevention, may have unique side effects that are still being evaluated, but they aim to reduce the chronic lung disease burden in extremely premature infants.

What prior FDA approvals exist?

The FDA has approved sildenafil for use in pediatric patients with pulmonary arterial hypertension, which is relevant to the treatment of severe bronchopulmonary dysplasia (BPD) due to its role in managing pulmonary hypertension. Other treatments for BPD have included the use of corticosteroids to reduce inflammation and support lung function, though these are not specific FDA approvals for BPD but rather off-label uses. The investigational drug in the current study aims to prevent BPD, potentially adding to the therapeutic options available for this condition.

What other types of research exist?

Promising novel alternatives for preventing Bronchopulmonary Dysplasia in extremely premature infants include advancements in non-invasive ventilation strategies, the use of corticosteroids like budesonide, and the administration of surfactant therapy. Additionally, stem cell therapy and antioxidant treatments are being explored for their potential benefits in reducing the incidence and severity of BPD.

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OHB-607 for Bronchopulmonary Dysplasia

Q: What is the mechanism of action of this treatment?

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.

Phase 2

Recruiting

Research Sponsored by Shire

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be younger than 18 years old

Must not have

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.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from 6 months ca through 24 months ca

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a new medicine to see if it can prevent a serious lung condition in very premature babies. The goal is to see if this new treatment works better at protecting their lungs and reducing the chances of developing chronic lung disease.

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.

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.

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.

Eligibility Criteria

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

My blood sugar is very low even after taking glucose.

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

This trial's timeline: 3 weeks for screening, Varies for treatment, and from 6 months ca through 24 months ca for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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 study objectives

Exposure-response relationship between measured IGF-1 and Bronchopulmonary Dysplasia (BPD)

Exposure-response relationship between measured IGF-1 and Retinopathy of Prematurity (ROP)

Exposure-response relationship between measured IGF-1 and intraventricular hemorrhage (IVH)

+10 more

Side effects data

From 2008 Phase 3 trial • 137 Patients • NCT00125164

24%

Upper respiratory tract infection

16%

Headache

16%

Cough

12%

Otitis media

12%

Sinusitis

Ear pain

Pharyngitis streptococcal

Nasopharyngitis

Pain in extremity

Hypoglycemia

Cellulitis

Influenza

100%

80%

60%

40%

20%

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)

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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.

0 / 1Eligibility criteria met

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.