A Multicenter, Randomized, Open Label Trial of a New Animal Extracted Surfactant to Treat RDS in Preterm Infants

• Sponsor: University of Sao Paulo (Other)
• Overall Status: Completed
• CT.gov ID: NCT02305160
• Collaborator: Ministry of Health, Brazil (Other)
• Enrollment: 327
• Locations: 30
• Arms: 2
• Duration (Months): 27
• Patients Per Site: 10.9
• Patients Per Site Per Month: 0.4

Study Details

Study Description

Brief Summary

The purpose of this study is to determine the efficacy and safety of the new pulmonary surfactant produced by Butantan Institute among premature infants with gestational age below 34 weeks with RDS, comparing to the pulmonary surfactants commercially available in Brazil.

Condition or Disease	Intervention/Treatment	Phase
Respiratory Distress Syndrome	Drug: Butantan; Drug: Control	Phase 2/Phase 3

Detailed Description

Exogenous surfactant replacement therapy has been one of the major advances in the treatment of premature infants with respiratory distress syndrome (RDS). It has decreased the mortality among premature infants with RDS, determining changes in the children mortality rates among the developed countries. High cost, however, has been a major handicap for its wide use in developing and underdeveloped countries. Based on that, Butantan Institute (Sao Paulo, Brazil) has developed a new porcine pulmonary surfactant preparation at lower production cost. Initial animal studies showed similar improvement in lung mechanics and histopathologic findings to those observed with commercially available preparations.

Comparison(s): The new surfactant developed and produced by Butantan Institute will be compared to the commercially available pulmonary surfactants in Brazil, regarding to the efficiency to maintain a good arterial oxygenation, low airway pressures after treatment, similar mortality rates, and similar rates of complications like bronchopulmonary dysplasia and pulmonary hemorrhage.

Study Design

• Study Type: Interventional
• Actual Enrollment: 327 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Phase 3 Multicenter, Randomized, Open Label Trial of a New Low Cost Animal Extracted Surfactant to Treat Respiratory Distress Syndrome in Preterm Infants
• Study Start Date: Apr 1, 2005
• Actual Primary Completion Date: May 1, 2006
• Actual Study Completion Date: Jul 1, 2007

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Butantan The new pulmonary surfactant produced by Butantan Institute. Butantan Surfactant: 100 mg/kg, IT, maximum of 3 doses.	Drug: Butantan; Use of Butantan surfactant 100 mg/kg, IT, maximum of 3 doses; Other Names: Butantan Surfactant
Active Comparator: Control The pulmonary surfactants commercially available in Brazil Survanta or Curosurf: 100 mg/kg, IT, maximum of 3 doses.	Drug: Control; The pulmonary surfactants commercially available in Brazil Survanta or Curosurf: 100 mg/kg, IT, maximum of 3 doses.; Other Names: Survanta or Curosurf

Outcome Measures

Primary Outcome Measures

1. Mortality rate [72 hours after treatment]

   Mortality rate 72 hours after treatment

Secondary Outcome Measures

1. The incidence of adverse effects as: pneumothorax, pneumomediastinum, pulmonary interstitial emphysema, pulmonary hemorrhage and bronchopulmonary dysplasia (BPD). [28 days of life]

   Incidence of main complications of prematurity at 28 days of life.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 1 Minute to 24 Hours
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Gestational age below 34 weeks

• RDS diagnosis based on clinical and RDS radiographic patterns

• Need of mechanical ventilation

• Parental consent

Exclusion Criteria:

• Age greater than 24 hours

• Major congenital malformations

• Unstable hemodynamic status

• Occurence of seizure during the stay in the Neonatal Intensive Care Unit

• Maternal and/or fetal infection (chorioamnionitis: maternal fever, foul vaginal discharge, fetal tachycardia, uterine tenderness, leukocytosis or leukopenia) or congenital infection

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Hospital Esau de Matos	Vitoria da Conquista	BA	Brazil	45065-540
2	Hospital Regional de Taguatinga	Brasilia	DF	Brazil	70673-423
3	Hospital Materno Infantil	Goiania	GO	Brazil	74673-200
4	Hospital Universitario - Unidade Materno Infantil	Sao Luis	MA	Brazil	65020-460
5	Maternidade Odete Valadares	Belo Horizonte	MG	Brazil	30110-130
6	Santa Casa de Misericórdia de BH	Belo Horizonte	MG	Brazil	30140-080
7	Hospital de Clínicas de Minas Gerais	Belo Horizonte	MG	Brazil	30180-112
8	Hospital Sofia feldman	Belo Horizonte	MG	Brazil	30260-020
9	Hospital Municipal Odilon Behrens	Belo Horizonte	MG	Brazil	30575-740
10	Hospital Julia Kubstchek	Belo Horizonte	MG	Brazil	30620-470
11	IMIP	Recife	PE	Brazil	50070-550
12	Hospital Barao de Lucena	Recife	PE	Brazil	50731-000
13	CISAM - Universidade de Pernambuco	Recife	PE	Brazil	52030-010
14	Hospital Maternidade Oswaldo de Nazareth	Rio de janeiro	RJ	Brazil	20010-010
15	Hospital Maternidade Carmela Dutra	Rio de Janeiro	RJ	Brazil	20720-292
16	Hospital Maternidade Alexandre Fleming	Rio de Janeiro	RJ	Brazil	21610-645
17	Hospital Geral de Bonsucesso	Rio de Janeiro	RJ	Brazil	22040-000
18	Instituto Fernandes Figueira	Rio de Janeiro	RJ	Brazil	22250-020
19	Hospital Cachoeirinha	Cachoeirinha	RS	Brazil	94950-585
20	Hospital Femina	Porto Alegre	RS	Brazil	91430-001
21	Grupo Hospital Criança Conceicao	Porto Alegre	RS	Brazil
22	Hospital Alvorada	Porto Alegre	RS	Brazil
23	Faculdade de Medicina de Botucatu - UNESP	Botucatu	Sao Paulo	Brazil	18601-020
24	Universidade de Campinas - UNICAMP	Campinas	Sao Paulo	Brazil	13083-881
25	HC da Fac. de Medicina de Ribeirão Preto - USP	Ribeirão Preto	Sao Paulo	Brazil	14049-900
26	Hospital Santa Isabel	Aracaju	SE	Brazil	49060-640
27	Maternidade Hildete Falcao Batista	Aracaju	SE	Brazil	49085-310
28	Matern. Escola de Vila Nova Cachoeirinha	Sao Paulo	SP	Brazil	01224-010
29	Instituto da Criança - HCFMUSP	Sao Paulo	SP	Brazil	05403-900
30	Hospital Universitario - USP	Sao Paulo	SP	Brazil	05508900

Sponsors and Collaborators

• University of Sao Paulo
• Ministry of Health, Brazil

Investigators

• Study Director: Alexander R Precioso, MD PhD, University of Sao Paulo Medical School Department of Pediatrics
• Principal Investigator: Celso M Rebello, MD PhD, University of Sao Paulo Medical School - Department of Pediatrics
• Study Director: Renata S Mascaretti, MD PhD, University of Sao Paulo Medical School Department of Pediatrics

Study Documents (Full-Text)

None provided.

More Information

Publications

• Lyra JC, Mascaretti RS, Precioso AR, Haddad LB, Mauad T, Vaz FA, Rebello CM. Polyethylene glycol addition does not improve exogenous surfactant function in an experimental model of meconium aspiration syndrome. Exp Lung Res. 2009 Feb;35(1):76-88. doi: 10.1080/01902140802415837.
• Precioso AR, Sakae PP, Mascaretti RS, Kubrusly FS, Gebara VC, Iourtov D, Rebello CM, Vaz FA, Raw I. Analysis of the immunogenicity and stability of a porcine pulmonary surfactant preparation administered in rabbits. Clinics (Sao Paulo). 2006 Apr;61(2):153-60. Epub 2006 Apr 25.

• Responsible Party: Celso Moura Rebello, MD PhD, University of Sao Paulo
• ClinicalTrials.gov Identifier: NCT02305160
• Other Study ID Numbers: 012005B
• First Posted: Dec 2, 2014
• Last Update Posted: Dec 2, 2014
• Last Verified: Nov 1, 2014

• Keywords provided by Celso Moura Rebello, MD PhD, University of Sao Paulo: Respiratory distress syndrome; Pulmonary surfactant; Mortality; Prematurity
• Additional relevant MeSH terms: Respiratory Distress Syndrome; Respiratory Distress Syndrome, Newborn; Syndrome; Poractant alfa; Beractant

Study Results

No Results Posted as of Dec 2, 2014