Surfactant Administration During Spontaneous Breathing

NCT ID: NCT01329432

Last Updated: 2011-04-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-12-31

Study Completion Date

2011-12-31

Brief Summary

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Spontaneous breathing supported by nasal continuous positive airway pressure (nCPAP) is thought to have some advantages compared with mechanical ventilation in premature infants. In addition, early surfactant administration has been shown to be superior to delayed use. The aim of this pilot study was to describe the feasibility of TAKE CARE (early administration of surfactant in spontaneous breathing) procedure and compare its short-term and long-term results with InSurE procedure.

Detailed Description

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In TAKE CARE procedure all premature infants who suffered from respiratory distress syndrome (RDS) received 100 mg/kg of porcine surfactant preparation via an intratracheal catheter during spontaneous breathing. In the control group infants treated with InSurE procedure were intubated and ventilated to receive surfactant and placed on nCPAP rapidly after surfactant administration. The procedures were compared for short-term efficacy and possible complications.

Conditions

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Pneumothorax Pulmonary Interstitial Emphysema Bronchopulmonary Dysplasia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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take care

In TAKE CARE procedure all premature infants who suffered from respiratory distress syndrome (RDS) received 100 mg/kg of porcine surfactant preparation via an intratracheal catheter during spontaneous breathing

Group Type SHAM_COMPARATOR

Take care

Intervention Type PROCEDURE

In TAKE CARE procedure all premature infants who suffered from respiratory distress syndrome (RDS) received 100 mg/kg of porcine surfactant preparation via an intratracheal catheter during spontaneous breathing.

InSurE

infants treated with InSurE procedure were intubated and ventilated to receive surfactant and placed on nCPAP rapidly after surfactant administration

Group Type EXPERIMENTAL

InSurE

Intervention Type PROCEDURE

infants treated with InSurE procedure were intubated and ventilated to receive surfactant and placed on nCPAP rapidly after surfactant administration.

Interventions

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Take care

In TAKE CARE procedure all premature infants who suffered from respiratory distress syndrome (RDS) received 100 mg/kg of porcine surfactant preparation via an intratracheal catheter during spontaneous breathing.

Intervention Type PROCEDURE

InSurE

infants treated with InSurE procedure were intubated and ventilated to receive surfactant and placed on nCPAP rapidly after surfactant administration.

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* All infants who presented with clinical anl laboratory signs of RDS

Exclusion Criteria

* infants who required intubation or PPV right after birth
Minimum Eligible Age

23 Weeks

Maximum Eligible Age

35 Weeks

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Zekai Tahir Burak Women's Health Research and Education Hospital

OTHER

Sponsor Role lead

Responsible Party

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Zekai Tahir Burak Maternity Teaching Hospital, Neonatal Intensive care Unit

Locations

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Zekai tahir Burak Materntiy Teaching Hospital, Neonatal Intensive Care Unit

Ankara, , Turkey (Türkiye)

Site Status RECRUITING

Countries

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Turkey (Türkiye)

Central Contacts

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Gozde Kanmaz, MD

Role: CONTACT

+90 505 588 11 89

Omer Erdeve, MD

Role: CONTACT

+90 312 306 56 76

Facility Contacts

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Gozde Kanmaz, MD

Role: primary

+ 90 505 588 11 89

Omer Erdeve, MD

Role: backup

+90 312 306 56 76

References

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Kribs A, Hartel C, Kattner E, Vochem M, Kuster H, Moller J, Muller D, Segerer H, Wieg C, Gebauer C, Nikischin W, Wense Av, Herting E, Roth B, Gopel W. Surfactant without intubation in preterm infants with respiratory distress: first multi-center data. Klin Padiatr. 2010 Jan-Feb;222(1):13-7. doi: 10.1055/s-0029-1241867. Epub 2010 Jan 18.

Reference Type RESULT
PMID: 20084586 (View on PubMed)

Other Identifiers

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2011-019

Identifier Type: -

Identifier Source: org_study_id

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