Comparison of Two Strategies for Surfactant Prophylaxis in Premature Infants

June 21, 2011 updated by: Ankara University

A Randomized Trial: Comparison of Two Strategies for Surfactant Prophylaxis in Premature Infants

The purpose of this study is to determine whether the immediate bolus strategy combined with early nasal CPAP (nCPAP) treatment could decrease the subsequent need for ventilation compared to the administration of surfactant prophylaxis at 15 minutes after birth with early nCPAP in premature infants.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Respiratory distress syndrome (RDS) is a syndrome in premature infants caused by developmental insufficiency of surfactant production and structural immaturity in the lungs. Exogenous surfactant therapy has become well established in newborn infants with RDS. Surfactant replacement therapy, either as a rescue treatment or a prophylactic, reduces mortality and several aspects of morbidity in babies with RDS. It is known that infants who are at a significant risk of RDS should receive prophylactic surfactant therapy, but the optimal timing and strategy for prophylactic surfactant therapy remains controversial. When administered immediately after delivery, surfactant mixes with the fetal lung fluid and reaches the alveoli before the onset of lung injury potentially created by the first applied positive pressure ventilation. As another approach, surfactant prophylaxis may be administered after resuscitation and stabilization.

Study Type

Interventional

Enrollment (Anticipated)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Turkey
      • Ankara, Turkey, 06620
        • Recruiting
        • Ankara University Faculty of Medicine Department of Pediatrics
        • Contact:
        • Contact:
        • Principal Investigator:
          • Emel Okulu, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 minute to 2 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Premature infants born before 28 weeks' gestation
  • Premature infants born at 29 to 30 weeks' gestation who did not receive antenatal steroid were randomized before delivery

Exclusion Criteria:

  • Infants died at delivery room

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: immediate bolus surfactant
Other: surfactant prophylaxis
Premature infants born before 28 weeks' gestation and infants born at 29 to 30 weeks' gestation who did not receive antenatal steroid were randomized before delivery to receive either immediate bolus or post-resuscitation surfactant prophylaxis at 15 minutes after birth. Those infants who were randomized to immediate bolus surfactant were intubated as rapidly as possible after birth, were administered 100 mg/kg surfactant (Curosurf[Chiesi, Farmaceutici, Parma, Italy]), and received standard resuscitation measures as indicated. Those infants who were randomized to post-resuscitation surfactant received standard resuscitation measures first, were intubated electively at 15 minutes after birth and received 100 mg/kg surfactant (Curosurf[Chiesi, Farmaceutici, Parma, Italy]).
Experimental: post-resuscitation surfactant
Other: surfactant prophylaxis
Premature infants born before 28 weeks' gestation and infants born at 29 to 30 weeks' gestation who did not receive antenatal steroid were randomized before delivery to receive either immediate bolus or post-resuscitation surfactant prophylaxis at 15 minutes after birth. Those infants who were randomized to immediate bolus surfactant were intubated as rapidly as possible after birth, were administered 100 mg/kg surfactant (Curosurf[Chiesi, Farmaceutici, Parma, Italy]), and received standard resuscitation measures as indicated. Those infants who were randomized to post-resuscitation surfactant received standard resuscitation measures first, were intubated electively at 15 minutes after birth and received 100 mg/kg surfactant (Curosurf[Chiesi, Farmaceutici, Parma, Italy]).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
ventilatory requirement
Time Frame: within the first 5 days of life
Infants with RDS may require mechanical ventilation. Mechinal ventilation causes volu- and barotrauma in the lungs and associated morbidities. The earlier surfactant is given, the better it works. So immediate surfactant prophylaxis given before the first breath may decrease the requirement for mechanical ventilation compared with surfactant prophylaxis given at 15 minutes of age after resuscitation and stabilization.
within the first 5 days of life

Secondary Outcome Measures

Outcome Measure
Time Frame
Pneumothorax
Time Frame: first 72 hours of life
first 72 hours of life
Pulmonary hemorrhage
Time Frame: first 72 hours of life
first 72 hours of life
patent ductus arteriosus
Time Frame: first one week
first one week
necrotizing enterocolitis
Time Frame: first one month
first one month
retinopathy of prematurity
Time Frame: first two months
first two months
intraventricular hemorrhage
Time Frame: first one week
first one week
bronchopulmonary dysplasia
Time Frame: first two months
first two months
duration of hospitalization
Time Frame: one year
one year
mortality
Time Frame: one year
one year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ankara University

Investigators

  • Study Director: Saadet Arsan, Professor, Ankara University Faculty of Medicine
  • Principal Investigator: Emel Okulu, MD, Ankara University Faculty of Medicine

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2010

Primary Completion (Anticipated)

January 1, 2012

Study Completion (Anticipated)

June 1, 2012

Study Registration Dates

First Submitted

February 11, 2011

First Submitted That Met QC Criteria

February 11, 2011

First Posted (Estimate)

February 14, 2011

Study Record Updates

Last Update Posted (Estimate)

June 22, 2011

Last Update Submitted That Met QC Criteria

June 21, 2011

Last Verified

December 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Ankara University-01
  • Ankara University (OTHER_GRANT: Ankara University Research Fund (10B3330012))

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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