Comparison of Two Strategies for Surfactant Prophylaxis in Premature Infants

Premature Birth Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01294852
• Other study ID #: Ankara University-01
• Secondary ID: Ankara Universit
• Status: Recruiting
• Phase: N/A
• First received: February 11, 2011
• Last updated: June 21, 2011
• Start date: January 2010
• Est. completion date: June 2012

Study information

• Verified date: December 2009
• Source: Ankara University
• Contact: Saadet Arsan, Professor
• Phone: 90 312 5956390
• Email: Saadet.Arsan[@]medicine.ankara.edu.tr
• Is FDA regulated: No
• Health authority: Turkey: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: June 2012
• Est. primary completion date: January 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 2 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Premature Birth
• Premature Lungs

Intervention

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]).

Locations

Country	Name	City	State
Turkey	Ankara University Faculty of Medicine Department of Pediatrics	Ankara

Sponsors (1)

Lead Sponsor	Collaborator
Ankara University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	ventilatory requirement	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	No
Secondary	Pneumothorax		first 72 hours of life	No
Secondary	Pulmonary hemorrhage		first 72 hours of life	No
Secondary	patent ductus arteriosus		first one week	No
Secondary	necrotizing enterocolitis		first one month	No
Secondary	retinopathy of prematurity		first two months	No
Secondary	intraventricular hemorrhage		first one week	No
Secondary	bronchopulmonary dysplasia		first two months	No
Secondary	duration of hospitalization		one year	No
Secondary	mortality		one year	No