Two Strategies of RDS Treatment in Newborns With Birth Weight > 1500 Grams

Comparative Trial of Two Strategies of RDS Treatment in Newborns With Birth Weight > 1500 Grams

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.

Study Overview

• Status: Unknown
• Conditions: Respiratory Distress Syndrome
• Intervention / Treatment: Drug: Surfactant; Device: Nasal CPAP

Detailed Description

Respiratory Distress Syndrome (RDS) is a frequent respiratory problem of preterm infants and an important cause of morbidity and mortality.

The management of this disease usually includes intubation, surfactant administration and mechanical ventilation in infants less than 1500 grams. However, in patients over this weight, the treatment has not been standardized and depends on the clinical progression of oxygen requirements.

Hypothesis:

- Early CPAP and selective surfactant administration is an effective treatment for RDS in infants >1500 g. This could decrease or avoid intubation and surfactant administration.

Comparison(s):

Early surfactant administration, when the FiO2 ≥ 0.4. compared to selective surfactant administration when the arterial to alveolar oxygen tension ratio (a/APO2) is ≤ 0.21.

• Study Type: Interventional
• Enrollment: 110
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Soledad Urzúa, MD; Phone Number: 56-2-3543348; Email: soleurzua@gmail.com
• Study Contact Backup: Name: Alvaro J Gonzalez, MD; Phone Number: 56-2-3543349; Email: alvgonza@med.puc.cl

Study Locations

• Chile
  • Región Metropolitana
    • Santiago, Región Metropolitana, Chile
      • Recruiting
      • Unidad de Neonatología, Hospital Clínico Pontificia Universidad Católica
      • Contact: Soledad Urzúa, MD; Phone Number: 56-2-3543348; Email: soleurzua@gmail.com
      • Principal Investigator: Soledad Urzúa, MD
      • Contact: Alvaro J Gonzalez, MD; Phone Number: 56-2-3543349; Email: alvgonza@med.puc.cl
    • Santiago, Región Metropolitana, Chile
      • Recruiting
      • Servicio de Neonatología, Hospital San José
      • Contact: German Muhlhausen, MD; Phone Number: 2731 56-2-3832600; Email: mygfam@mi.cl
      • Sub-Investigator: German Muhlhausen, MD
    • Santiago, Región Metropolitana, Chile
      • Recruiting
      • Servicio de Neonatología, Hospital Sótero del Rio
      • Contact: Patricia Mena, MD; Phone Number: 6535 56-2-3536000; Email: pmena@uec.uchile.cl
      • Sub-Investigator: Patricia Mena, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 5 minutes to 1 day (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
The need of intubation and surfactant administration.

Secondary Outcome Measures

Outcome Measure
Length of stay.
Mechanical ventilation and CPAP duration.
Oxygen therapy.
BPD incidence.
Enteral feeding tolerance.
Air leak.
NEC, gastric perforation.
Death.

Collaborators and Investigators

• Sponsor: Pontificia Universidad Catolica de Chile
• Collaborators: Sociedad Chilena de Pediatría
• Investigators: Principal Investigator: Soledad Urzua, MD, Pontificia Universidad Católica; Study Director: Alvaro Gonzalez, MD, Pontificia Universidad Católica

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start: January 1, 2006

Study Registration Dates

• First Submitted: January 5, 2006
• First Submitted That Met QC Criteria: January 11, 2006
• First Posted (Estimate): January 13, 2006

Study Record Updates

• Last Update Posted (Estimate): August 24, 2006
• Last Update Submitted That Met QC Criteria: August 22, 2006
• Last Verified: December 1, 2005

More Information

Terms related to this study

• Keywords: Surfactant; Nasal CPAP; Respiratory Distress Syndrome
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Respiration Disorders; Lung Diseases; Infant, Newborn, Diseases; Body Weight; Infant, Premature, Diseases; Birth Weight; Respiratory Distress Syndrome; Respiratory Distress Syndrome, Newborn; Respiratory System Agents; Pulmonary Surfactants
• Other Study ID Numbers: NEOUC022005