NCT01860014

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2010

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2010

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2011

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2011

Completed
2.2 years until next milestone

First Submitted

Initial submission to the registry

May 20, 2013

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 22, 2013

Completed
Last Updated

May 22, 2013

Status Verified

May 1, 2013

Enrollment Period

10 months

First QC Date

May 20, 2013

Last Update Submit

May 20, 2013

Conditions

Pulmonary Hemorrhage

Keywords

Pulmonary hemorrhageMortalityNewborn

Outcome Measures

Primary Outcomes (1)

  • Oxygen requirement

    We will evaluate the need of oxygen support within 6 hour after surfactant

    6 hour

Secondary Outcomes (1)

  • Mortality

    4 weeks

Study Arms (2)

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

Poractant alfaDRUG

Curosurf: 100 mg/kg-intratracheal, just after pulmonary hemorrhage

Also known as: Curosurf
Beractant
BeractantDRUG

Survanta: 100 mg/kg-intratracheal, just after pulmonary hemorrhage

Also known as: Survanta
Poractant alfa

Eligibility Criteria

Age1 Hour - 1 Week
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Premature infants \<1500 g
  • Within first week of life

You may not qualify if:

  • Major congenital abnormalities
  • Without parental consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Zekai Tahir Burak Hospital

Ankara, 06120, Turkey (Türkiye)

Location

Related Publications (1)

  • 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.

    PMID: 8095608RESULT

MeSH Terms

Interventions

poractant alfaberactant

Study Officials

  • Şenol Bozdağ, MD

    Zekai Tahir Burak Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

May 20, 2013

First Posted

May 22, 2013

Study Start

March 1, 2010

Primary Completion

January 1, 2011

Study Completion

March 1, 2011

Last Updated

May 22, 2013

Record last verified: 2013-05

Locations

TU(1)