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Comparison of Two Strategies for Surfactant Prophylaxis in Premature Infants

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ClinicalTrials.gov Identifier: NCT01294852
Recruitment Status : Unknown
Verified December 2009 by Ankara University.
Recruitment status was:  Recruiting
First Posted : February 14, 2011
Last Update Posted : June 22, 2011
Sponsor:
Information provided by:
Ankara University

Brief Summary:
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 or disease Intervention/treatment Phase
Premature Birth Premature Lungs Other: surfactant prophylaxis Not Applicable

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  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Prevention
Official Title: A Randomized Trial: Comparison of Two Strategies for Surfactant Prophylaxis in Premature Infants
Study Start Date : January 2010
Estimated Primary Completion Date : January 2012
Estimated Study Completion Date : June 2012

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]).



Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Pneumothorax [ Time Frame: first 72 hours of life ]
  2. Pulmonary hemorrhage [ Time Frame: first 72 hours of life ]
  3. patent ductus arteriosus [ Time Frame: first one week ]
  4. necrotizing enterocolitis [ Time Frame: first one month ]
  5. retinopathy of prematurity [ Time Frame: first two months ]
  6. intraventricular hemorrhage [ Time Frame: first one week ]
  7. bronchopulmonary dysplasia [ Time Frame: first two months ]
  8. duration of hospitalization [ Time Frame: one year ]
  9. mortality [ Time Frame: one year ]


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Ages Eligible for Study:   up to 2 Years   (Child)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

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 ( Other Grant/Funding Number: Ankara University Research Fund (Number 10B3330010) )
First Posted: February 14, 2011    Key Record Dates
Last Update Posted: June 22, 2011
Last Verified: December 2009

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

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