Comparison of Two Strategies for Surfactant Prophylaxis in Premature Infants

The recruitment status of this study is unknown because the information has not been verified recently.
Verified December 2009 by Ankara University.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Ankara University
ClinicalTrials.gov Identifier:
NCT01294852
First received: February 11, 2011
Last updated: June 21, 2011
Last verified: December 2009
  Purpose

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.


Condition Intervention
Premature Birth
Premature Lungs
Other: surfactant prophylaxis

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Prevention
Official Title: A Randomized Trial: Comparison of Two Strategies for Surfactant Prophylaxis in Premature Infants

Further study details as provided by Ankara University:

Primary Outcome Measures:
  • ventilatory requirement [ Time Frame: within the first 5 days of life ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Pneumothorax [ Time Frame: first 72 hours of life ] [ Designated as safety issue: No ]
  • Pulmonary hemorrhage [ Time Frame: first 72 hours of life ] [ Designated as safety issue: No ]
  • patent ductus arteriosus [ Time Frame: first one week ] [ Designated as safety issue: No ]
  • necrotizing enterocolitis [ Time Frame: first one month ] [ Designated as safety issue: No ]
  • retinopathy of prematurity [ Time Frame: first two months ] [ Designated as safety issue: No ]
  • intraventricular hemorrhage [ Time Frame: first one week ] [ Designated as safety issue: No ]
  • bronchopulmonary dysplasia [ Time Frame: first two months ] [ Designated as safety issue: No ]
  • duration of hospitalization [ Time Frame: one year ] [ Designated as safety issue: No ]
  • mortality [ Time Frame: one year ] [ Designated as safety issue: No ]

Estimated Enrollment: 100
Study Start Date: January 2010
Estimated Study Completion Date: June 2012
Estimated Primary Completion Date: January 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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]).

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.

  Eligibility

Ages Eligible for Study:   up to 2 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01294852

Contacts
Contact: Saadet Arsan, Professor 90 312 5956390 Saadet.Arsan@medicine.ankara.edu.tr
Contact: Emel Okulu, MD 90 312 5956390 emelderelli@hotmail.com

Locations
Turkey
Ankara University Faculty of Medicine Department of Pediatrics Recruiting
Ankara, Turkey, 06620
Contact: Saadet Arsan, Professor    90 312 5956390    Saadet.Arsan@medicine.ankara.edu.tr   
Contact: Emel Okulu, MD    90 312 5956390    emelderelli@hotmail.com   
Principal Investigator: Emel Okulu, MD         
Sponsors and Collaborators
Ankara University
Investigators
Study Director: Saadet Arsan, Professor Ankara University Faculty of Medicine
Principal Investigator: Emel Okulu, MD Ankara University Faculty of Medicine
  More Information

No publications provided

Responsible Party: Ankara University Faculty of Medicine, Ankara University
ClinicalTrials.gov Identifier: NCT01294852     History of Changes
Other Study ID Numbers: Ankara University-01, Ankara University
Study First Received: February 11, 2011
Last Updated: June 21, 2011
Health Authority: Turkey: Ethics Committee

Keywords provided by Ankara University:
prophylactic
surfactant
premature
mechanical ventilation
mortality
morbidities

Additional relevant MeSH terms:
Premature Birth
Obstetric Labor Complications
Obstetric Labor, Premature
Pregnancy Complications
Pulmonary Surfactants
Pharmacologic Actions
Respiratory System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on October 22, 2014