Comparison of Two Strategies for Surfactant Prophylaxis in Premature Infants

NCT01294852 | Unknown

• 2 other identifiers: Ankara University-01Ankara University
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Premature Birth; Premature Lungs

Keywords

prophylactic; surfactant; premature; mechanical ventilation; mortality; morbidities

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (9)

• Pneumothorax

  first 72 hours of life

• Pulmonary hemorrhage

  first 72 hours of life

• patent ductus arteriosus

  first one week

• necrotizing enterocolitis

  first one month

• retinopathy of prematurity

  first two months

Study Arms (2)

immediate bolus surfactant

EXPERIMENTAL

Other: surfactant prophylaxis

post-resuscitation surfactant

EXPERIMENTAL

Other: surfactant prophylaxis

Interventions

surfactant prophylaxis OTHER

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\[Chiesi, Farmaceutici, Parma, Italy\]).

immediate bolus surfactant; post-resuscitation surfactant

Eligibility Criteria

• Age: 1 Minute - 2 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• Infants died at delivery room

Sponsors & Collaborators

• Ankara University: lead

Study Sites (1)

Ankara University Faculty of Medicine Department of Pediatrics

Ankara, 06620, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Premature Birth

Condition Hierarchy (Ancestors)

Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Study Officials

• Saadet Arsan, Professor

  Ankara University Faculty of Medicine

  STUDY DIRECTOR

• Emel Okulu, MD

  Ankara University Faculty of Medicine

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Saadet Arsan, Professor

CONTACT

90 312 5956390; Saadet.Arsan@medicine.ankara.edu.tr

Emel Okulu, MD

CONTACT

90 312 5956390; emelderelli@hotmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: February 11, 2011
• First Posted: February 14, 2011
• Study Start: January 1, 2010
• Primary Completion: January 1, 2012
• Study Completion: June 1, 2012
• Last Updated: June 22, 2011

Record last verified: 2009-12

Locations

TU (1)