Comparison of Two Different Natural Surfactants in the Tr... | NCT01860014

Studies
Comparison of Two Different Natural Surfactants in the Treatment of Pulmonary Hemorrhage

NCT01860014

Sponsor

Dr. Sami Ulus Children's Hospital

Status

Completed

Last Update Posted

May 22, 2013Estimated

Enrollment

20Actual

Phase

Not Applicable

Conditions

Pulmonary Hemorrhage

Interventions

Poractant alfa
Beractant

Countries

Turkey (Türkiye)

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

Annotation Module

Unposted Annotation

Unposted Responsible Party

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
306/29 March 2010	Other Identifier	Ethics Committee

Status Module

Record Verification Date

May 2013

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 2010

Primary Completion Date

Jan 2011Actual

Completion Date

Mar 2011Actual

First Submitted Date

May 20, 2013

First Submission Date that Met QC Criteria

May 20, 2013

First Posted Date

May 22, 2013Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 20, 2013

Last Update Posted Date

May 22, 2013Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Dilek Dilli, MD, Dr. Sami Ulus Children's HospitalPrincipal Investigator

Lead Sponsor

Dr. Sami Ulus Children's HospitalOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The incidence of pulmonary hemorrhage (PH) was about 1.3 per 1,000 live births. PH occurs mainly in preterm ventilated infants with severe respiratory distress syndrome (RDS) who often have a PDA and have received surfactant. Although not clear, the cause of PH is thought to be due to a rapid lowering of intrapulmonary pressure, which facilitates left to right shunting across a patent ductus arteriosus and an increase in pulmonary blood flow. Prospective uncontrolled studies that used surfactant for PH in neonates have shown promising results in treating PH.In this study we aimed to evaluate the effect of two different natural surfactants in neonates with pulmonary hemorrhage.

Detailed Description

The incidence of PH was about 1.3 per 1,000 live births. Formerly,the risk factors associated with PH included the severity of the associated illness, intrauterine growth restriction, patent ductus arteriosus (PDA), coagulopathy, and the need for assisted ventilation. Currently, PH occurs mainly in preterm ventilated infants with severe respiratory distress syndrome (RDS) who often have a PDA and have received surfactant. Currently, PH complicates the hospital course of 3-5% of preterm infants with RDS. The cause of PH is thought to be due to a rapid lowering of intrapulmonary pressure, which facilitates left to right shunting across a patent ductus arteriosus and an increase in pulmonary blood flow. Prospective uncontrolled studies that used surfactant for PH in neonates have shown promising results in treating PH.In this study we aimed to evaluate the effect of two different natural surfactants in neonates with pulmonary hemorrhage.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

20Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Beractant	Active Comparator	Beractant (Survanta): 100 mg/kg-intratracheal, just after pulmonary hemorrhage	Drug: Poractant alfa
Poractant alfa	Active Comparator	Poractant alfa (Curosurf): 100 mg/kg-intratracheal, just after pulmonary hemorrhage	Drug: Beractant

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Poractant alfa	Drug	Curosurf: 100 mg/kg-intratracheal, just after pulmonary hemorrhage	Beractant

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Oxygen requirement	We will evaluate the need of oxygen support within 6 hour after surfactant	6 hour

Secondary Outcomes

Measure	Description	Time Frame
Mortality	We will compare the rate of mortality between the groups during neonatal period	4 weeks

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Premature infants <1500 g
Within first week of life

Exclusion Criteria:

Major congenital abnormalities
Without parental consent

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

1 Hour

Maximum Age

1 Week

Standard Ages

Child

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Şenol Bozdağ, MD	Zekai Tahir Burak Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Zekai Tahir Burak Hospital		Ankara		06120	Turkey (Türkiye)

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
8095608	Result	Rogers D. Pulmonary haemorrhage, surfactant, and low-birthweight babies. Lancet. 1993 Mar 13;341(8846):698. doi: 10.1016/0140-6736(93)90469-w. No abstract available.

Type	Date	Date Unknown
Release	Jun 13, 2013
Reset	Aug 20, 2013

ID	Term
C068291	poractant alfa
C072197	beractant