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Use of surfactant with corticosteroids to prevent chronic lung disease in premature infants

Intratracheal instillation of budesonide, using surfactant as a vehicle, in the prophylaxis and rescue therapy of neonatal respiratory distress syndrome to prevent bronchopulmonary dysplasia: a randomized clinical trial

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
REBEC
Registry ID
RBR-72kkgc
Enrollment
Unknown
Registered
2015-06-23
Start date
2013-03-13
Completion date
Unknown
Last updated
2025-10-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bronchopulmonary dysplasia originating in the perinatal period

Interventions

Experimental group: 45 premature infants receive budesonide associated with intratracheal surfactant, in the first two hours of life to prevent bronchopulmonary dysplasia. The medication once will be
Drug
P27.1

Sponsors

Hospital das Clínicas da Universidade Federal de Goiás
Lead Sponsor
Hospital das Clínicas da Universidade Federal de Goiás
Collaborator

Eligibility

Age
0 Hours to 2 Hours

Inclusion criteria

Inclusion criteria: Every newborn with 0-2 hours of life; both sexes; who required prophylactic surfactant or early redemption replacement therapy. Sample size target: 90 research subjects.

Exclusion criteria

Exclusion criteria: Loss of follow-up of the newborn before 28 days of chronological age (except in case of death); Congenital malformations of heart and lung; except patent ductus arteriosus and pervious foramen ovale.

Design outcomes

Primary

MeasureTime frame
Improvement in respiratory status increase survival rate and/or decrease bronchopulmonary dysplasia—

Secondary

MeasureTime frame
Early intratracheal instillation of a budesonide-surfactant mixture improve the respiratory status in preterm infants with moderate to severe respiratory distress syndrome—

Countries

Brazil

Contacts

Public ContactFernanda Peixoto

Hospital das Clínicas da Universidade Federal de Goiás

fernandapeixoto20@gmail.com+55(62)32698397

Outcome results

None listed

Source: REBEC (via WHO ICTRP)