NCT00277030

Brief Summary

The purpose of this study is to compare two different treatment strategies for RDS in preterm infants \> 1500 grams and evaluate whether a selective surfactant administration would reduce the need of intubation, mechanical ventilation and surfactant use.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
110

participants targeted

Target at P50-P75 for phase_4

Geographic Reach
1 country

3 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2006

Completed
4 days until next milestone

First Submitted

Initial submission to the registry

January 5, 2006

Completed
8 days until next milestone

First Posted

Study publicly available on registry

January 13, 2006

Completed
Last Updated

August 24, 2006

Status Verified

December 1, 2005

First QC Date

January 5, 2006

Last Update Submit

August 22, 2006

Conditions

Respiratory Distress Syndrome

Keywords

Respiratory Distress SyndromeSurfactantNasal CPAP

Outcome Measures

Primary Outcomes (1)

  • The need of intubation and surfactant administration.

Secondary Outcomes (8)

  • Mechanical ventilation and CPAP duration.

  • Oxygen therapy.

  • BPD incidence.

  • Length of stay.

  • Enteral feeding tolerance.

  • +3 more secondary outcomes

Interventions

SurfactantDRUG
Nasal CPAPDEVICE

Eligibility Criteria

Age5 Minutes - 1 Day
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Birth Weight \> 1500 g.
  • First day of life.
  • Clinical and radiological signs of RDS.
  • Oxygen requirement over 30% to reach an oxygen saturation of 88%.
  • Parent's consent approved.

You may not qualify if:

  • Neonatal asphyxia, 5 minute Apgar \< 3 or cord pH \<7.0.
  • Cardiac or respiratory malformation.
  • Chromosomal disease.
  • Significative pneumothorax.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Servicio de Neonatología, Hospital San José

Santiago, Santiago Metropolitan, Chile

RECRUITING

Servicio de Neonatología, Hospital Sótero del Rio

Santiago, Santiago Metropolitan, Chile

RECRUITING

Unidad de Neonatología, Hospital Clínico Pontificia Universidad Católica

Santiago, Santiago Metropolitan, Chile

RECRUITING

Related Publications (19)

  • Gregory GA, Kitterman JA, Phibbs RH, Tooley WH, Hamilton WK. Treatment of the idiopathic respiratory-distress syndrome with continuous positive airway pressure. N Engl J Med. 1971 Jun 17;284(24):1333-40. doi: 10.1056/NEJM197106172842401. No abstract available.

    PMID: 4930602BACKGROUND

  • Saunders RA, Milner AD, Hopkin IE. The effects of continuous positive airway pressure on lung mechanics and lung volumes in the neonate. Biol Neonate. 1976;29(3-4):178-86. doi: 10.1159/000240862.

    PMID: 782570BACKGROUND

  • Shaffer TH, Koen PA, Moskowitz GD, Ferguson JD, Delivoria-Papadopoulos M. Positive end expiratory pressure: effects on lung mechanics of premature lambs. Biol Neonate. 1978;34(1-2):1-10. doi: 10.1159/000241098.

    PMID: 359057BACKGROUND

  • Lindner W, Vossbeck S, Hummler H, Pohlandt F. Delivery room management of extremely low birth weight infants: spontaneous breathing or intubation? Pediatrics. 1999 May;103(5 Pt 1):961-7. doi: 10.1542/peds.103.5.961.

    PMID: 10224173BACKGROUND

  • Fujiwara T, Maeta H, Chida S, Morita T, Watabe Y, Abe T. Artificial surfactant therapy in hyaline-membrane disease. Lancet. 1980 Jan 12;1(8159):55-9. doi: 10.1016/s0140-6736(80)90489-4.

    PMID: 6101413BACKGROUND

  • Verder H, Albertsen P, Ebbesen F, Greisen G, Robertson B, Bertelsen A, Agertoft L, Djernes B, Nathan E, Reinholdt J. Nasal continuous positive airway pressure and early surfactant therapy for respiratory distress syndrome in newborns of less than 30 weeks' gestation. Pediatrics. 1999 Feb;103(2):E24. doi: 10.1542/peds.103.2.e24.

    PMID: 9925870BACKGROUND

  • Avery ME, Tooley WH, Keller JB, Hurd SS, Bryan MH, Cotton RB, Epstein MF, Fitzhardinge PM, Hansen CB, Hansen TN, et al. Is chronic lung disease in low birth weight infants preventable? A survey of eight centers. Pediatrics. 1987 Jan;79(1):26-30.

    PMID: 3797169BACKGROUND

  • Gerard P, Fox WW, Outerbridge EW, Beaudry PH. Early versus late introduction of continuous negative pressure in the management of the idiopathic respiratory distress syndrome. J Pediatr. 1975 Oct;87(4):591-5. doi: 10.1016/s0022-3476(75)80832-8.

    PMID: 1099184BACKGROUND

  • Krouskop RW, Brown EG, Sweet AY. The early use of continuous positive airway pressure in the treatment of idiopathic respiratory distress syndrome. J Pediatr. 1975 Aug;87(2):263-7. doi: 10.1016/s0022-3476(75)80599-3.

    PMID: 1097619BACKGROUND

  • Hegyi T, Hiatt IM. The effect of continuous positive airway pressure on the course of respiratory distress syndrome: the benefits on early initiation. Crit Care Med. 1981 Jan;9(1):38-41. doi: 10.1097/00003246-198101000-00009.

    PMID: 6780266BACKGROUND

  • Kamper J, Wulff K, Larsen C, Lindequist S. Early treatment with nasal continuous positive airway pressure in very low-birth-weight infants. Acta Paediatr. 1993 Feb;82(2):193-7. doi: 10.1111/j.1651-2227.1993.tb12637.x.

    PMID: 8477167BACKGROUND

  • Lundstrom KE. Initial treatment of preterm infants--continuous positive airway pressure or ventilation? Eur J Pediatr. 1996 Aug;155 Suppl 2:S25-9. doi: 10.1007/BF01958077.

    PMID: 8839743BACKGROUND

  • Finer NN, Carlo WA, Duara S, Fanaroff AA, Donovan EF, Wright LL, Kandefer S, Poole WK; National Institute of Child Health and Human Development Neonatal Research Network. Delivery room continuous positive airway pressure/positive end-expiratory pressure in extremely low birth weight infants: a feasibility trial. Pediatrics. 2004 Sep;114(3):651-7. doi: 10.1542/peds.2004-0394.

    PMID: 15342835BACKGROUND

  • Verder H, Robertson B, Greisen G, Ebbesen F, Albertsen P, Lundstrom K, Jacobsen T. Surfactant therapy and nasal continuous positive airway pressure for newborns with respiratory distress syndrome. Danish-Swedish Multicenter Study Group. N Engl J Med. 1994 Oct 20;331(16):1051-5. doi: 10.1056/NEJM199410203311603.

    PMID: 8090164BACKGROUND

  • Escobedo MB, Gunkel JH, Kennedy KA, Shattuck KE, Sanchez PJ, Seidner S, Hensley G, Cochran CK, Moya F, Morris B, Denson S, Stribley R, Naqvi M, Lasky RE; Texas Neonatal Research Group. Early surfactant for neonates with mild to moderate respiratory distress syndrome: a multicenter, randomized trial. J Pediatr. 2004 Jun;144(6):804-8. doi: 10.1016/j.jpeds.2004.03.024.

    PMID: 15192630BACKGROUND

  • Bernstein G, Mannino FL, Heldt GP, Callahan JD, Bull DH, Sola A, Ariagno RL, Hoffman GL, Frantz ID 3rd, Troche BI, Roberts JL, Dela Cruz TV, Costa E. Randomized multicenter trial comparing synchronized and conventional intermittent mandatory ventilation in neonates. J Pediatr. 1996 Apr;128(4):453-63. doi: 10.1016/s0022-3476(96)70354-2.

    PMID: 8618177BACKGROUND

  • Early versus delayed neonatal administration of a synthetic surfactant--the judgment of OSIRIS. The OSIRIS Collaborative Group (open study of infants at high risk of or with respiratory insufficiency--the role of surfactant. Lancet. 1992 Dec 5;340(8832):1363-9.

    PMID: 1360087BACKGROUND

  • Stevens TP, Blennow M, Soll RF. Early surfactant administration with brief ventilation vs selective surfactant and continued mechanical ventilation for preterm infants with or at risk for respiratory distress syndrome. Cochrane Database Syst Rev. 2004;(3):CD003063. doi: 10.1002/14651858.CD003063.pub2.

    PMID: 15266470BACKGROUND

  • Yost CC, Soll RF. Early versus delayed selective surfactant treatment for neonatal respiratory distress syndrome. Cochrane Database Syst Rev. 2000;(2):CD001456. doi: 10.1002/14651858.CD001456.

    PMID: 10796266BACKGROUND

MeSH Terms

Conditions

Respiratory Distress Syndrome

Interventions

Surface-Active Agents

Condition Hierarchy (Ancestors)

Lung DiseasesRespiratory Tract DiseasesRespiration Disorders

Intervention Hierarchy (Ancestors)

Specialty Uses of ChemicalsChemical Actions and Uses

Study Officials

  • Soledad Urzua, MD

    Pontificia Universidad Católica

    PRINCIPAL INVESTIGATOR

  • Alvaro Gonzalez, MD

    Pontificia Universidad Católica

    STUDY DIRECTOR

Central Study Contacts

Soledad Urzúa, MD

CONTACT

56-2-3543348soleurzua@gmail.com

Alvaro J Gonzalez, MD

CONTACT

56-2-3543349alvgonza@med.puc.cl

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

January 5, 2006

First Posted

January 13, 2006

Study Start

January 1, 2006

Last Updated

August 24, 2006

Record last verified: 2005-12

Locations

CL(3)