Cold Heart Study: A Randomized Pilot Trial of Surfactant Therapy

NCT04181255 | Terminated Phase 1 DMC FDA Drug

• 1 other identifier: HUM00160492
• Study Type: interventional
• Target: 2
• Locations: 1 country
• Sites: 1

Brief Summary

This clinical trial is being done to see if giving surfactant (Curosurf®) will decrease the number of days that infants will need a breathing tube, decrease the days in the critical care unit and decrease the number of days needed in the hospital. The primary hypothesis for this study is that there will be fewer days needed on mechanical ventilation and improved lung compliance and pulmonary gas exchange.

Conditions

Congenital Heart Disease; Hypoplastic Left Heart Syndrome

Keywords

Norwood procedure

Outcome Measures

Primary Outcomes (3)

• Number of days of mechanical ventilation

  This will be the number of days from intubation to the extubation date.

  Throughout hospitalization (approximate average 5 days)

• Number of days in the Pediatric Cardiothoracic Unit

  From time of admission until transfer out of the unit.

  Approximately 11 days

• Number of post-operative hospital days

  Up to 1 year

Secondary Outcomes (9)

• Total number of patients requiring thoracostomy tube placement for air leak not associated with standard post-operative management prior to extubation

  Approximately 1 week

• Total number of patients requiring high frequency ventilation (HFV) (High frequency oscillator ventilation or High frequency jet ventilation)

  Up to 1 year

• Total number of patients requiring extracorporeal membrane oxygenation (ECMO) for pulmonary failure

  Up to 1 year

• Changes in positive end-expiratory pressures post intervention

  Baseline to approximately 1 week

• Changes in peak inspiratory pressures post intervention

  Baseline to approximately 1 week

Study Arms (2)

Curosurf

EXPERIMENTAL

Drug: Curosurf

Sham (air)

PLACEBO COMPARATOR

Drug: Sham

Interventions

Curosurf DRUG

This arm will consist of a single dose of Curosurf (200 mg/kg) that will be given in the Pediatric Cardiothoracic Unit (PCTU) after surgery once the subject has reached a normalized body temperature.

Also known as: poractant alfa, surfactant

Curosurf

Sham DRUG

This arm will consist of a single dose of sham (air) that will be given through the endotracheal tube in the Pediatric Cardiothoracic Intensive Care Unit after surgery once the subject has reached a normalized body temperature.

Sham (air)

Eligibility Criteria

• Age: 1 Day - 12 Weeks
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Patients less than or equal to 12 weeks of age with hypoplastic left heart syndrome (HLHS) undergoing cardiothoracic surgical correction (Norwood) requiring DHCA.
• Infants weighing 2500 grams or greater at the time of surgery.
• Written informed consent from parent(s) or legally appointed representative (LAR).

You may not qualify if:

• Patients who are less than 36 weeks Post Menstrual Age (PMA) at the time of surgical correction.
• Underlying craniofacial, airway or lung anomalies which could compromise administration of surfactant.
• Infants weighing less than 2500 grams at the time of the surgical correction.
• Mechanical ventilation for\> 7 days prior to surgical correction.

Sponsors & Collaborators

• University of Michigan: lead
• Chiesi Farmaceutici S.p.A.: collaborator

Study Sites (1)

University of Michigan

Ann Arbor, Michigan, 48109, United States

Location

MeSH Terms

Conditions

Heart Defects, Congenital; Hypoplastic Left Heart Syndrome

Interventions

poractant alfa; Surface-Active Agents; salicylhydroxamic acid

Condition Hierarchy (Ancestors)

Cardiovascular Abnormalities; Cardiovascular Diseases; Heart Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Specialty Uses of Chemicals; Chemical Actions and Uses

Study Officials

• Steven Donn, MD

  University of Michigan

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor Emeritus of Pediatrics

Study Record Dates

• First Submitted: November 26, 2019
• First Posted: November 29, 2019
• Study Start: February 25, 2020
• Primary Completion: June 12, 2020
• Study Completion: June 12, 2020
• Last Updated: September 13, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)