Two Strategies of RDS Treatment in Newborns With Birth Weight > 1500 Grams - Full Text View

Purpose

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.

Condition	Intervention	Phase
Respiratory Distress Syndrome	Drug: Surfactant Device: Nasal CPAP	Phase 4

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	Comparative Trial of Two Strategies of RDS Treatment in Newborns With Birth Weight > 1500 Grams

Resource links provided by NLM:

MedlinePlus related topics: Birth Weight

U.S. FDA Resources

Further study details as provided by Pontificia Universidad Catolica de Chile:

Primary Outcome Measures:

The need of intubation and surfactant administration.

Secondary Outcome Measures:

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

Estimated Enrollment:	110
Study Start Date:	January 2006

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.

Eligibility

Ages Eligible for Study:	up to 1 Day
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00277030

Contacts

Contact: Soledad Urzúa, MD	56-2-3543348	soleurzua@gmail.com
Contact: Alvaro J Gonzalez, MD	56-2-3543349	alvgonza@med.puc.cl

Locations

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

Sponsors and Collaborators

Pontificia Universidad Catolica de Chile

Sociedad Chilena de Pediatría

Investigators

Principal Investigator:	Soledad Urzua, MD	Pontificia Universidad Católica
Study Director:	Alvaro Gonzalez, MD	Pontificia Universidad Católica

More Information

Publications:

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. No abstract available.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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

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.

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.

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.

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.

[No authors listed] 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. Review.

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

ClinicalTrials.gov Identifier:	NCT00277030 History of Changes
Other Study ID Numbers:	NEOUC022005
Study First Received:	January 5, 2006
Last Updated:	August 22, 2006
Health Authority:	Chile: Ministerio de Salud, Servicio de Salud Metropolitano Sur-Oriente

Keywords provided by Pontificia Universidad Catolica de Chile:

Respiratory Distress Syndrome
Surfactant
Nasal CPAP

Additional relevant MeSH terms:

Birth Weight
Respiratory Distress Syndrome, Newborn
Respiratory Distress Syndrome, Adult
Body Weight
Signs and Symptoms
Lung Diseases
Respiratory Tract Diseases

Respiration Disorders
Infant, Premature, Diseases
Infant, Newborn, Diseases
Pulmonary Surfactants
Respiratory System Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 16, 2013