NCT01268215

Brief Summary

A Pilot study to evaluate the safety and the efficacy of endotracheal instillation of pulmonary surfactant, with or without topical steroid (Budesonide), as a prophylactic treatment for Bronchopulmonary Dysplasia (a form of chronic lung disease) in extremely low birth weight infants. Cytokines (a group of inflammatory mediators) are measured in the tracheal aspirate before and after instillation of the study drugs.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
45

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Jul 2010

Typical duration for phase_2

Geographic Reach
1 country

1 active site

Status
unknown

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2010

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

December 28, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 29, 2010

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2012

Completed
1.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2013

Completed
Last Updated

December 29, 2010

Status Verified

July 1, 2010

Enrollment Period

1.9 years

First QC Date

December 28, 2010

Last Update Submit

December 28, 2010

Conditions

Bronchopulmonary Dysplasia

Keywords

Bronchopulmonary DysplasiaBudesonideInfasurf

Outcome Measures

Primary Outcomes (1)

  • To measure the effect of surfactant with and without Budesonide on the development of BPD in ELBW infants.

    The main goal of the study is to determine whether endotracheal instillation of surfactant (Infasurf) with or without potent topical steroid (Budesonide) reduces the development of Bronchopulmonary Dysplasia (BPD) in Extremely Low Birth Weight (ELBW) infants at high risk of BPD.

    Supplemental oxygen requirement at 36 weeks' postmenstrual age (PMA)

Secondary Outcomes (1)

  • To measure the effect of surfactant with and without Budesonide on the inflammatory cytokines in tracheal aspirates.

    The measurement of cytokines in tracheal aspirate samples will be done at the end of the study.

Study Arms (3)

A (two study drugs group)

EXPERIMENTAL

The standard management + two study drugs (endotracheal instillation of a mixture containing budesonide and Infasurf)

Drug: InfasurfDrug: Pulmicort

B (one study drug group)

ACTIVE COMPARATOR

The standard management + one study drug (endotracheal instillation of Infasurf only).

Drug: Infasurf

C (no study drug group)

SHAM COMPARATOR

The standard management only.

Other: Sham

Interventions

InfasurfDRUG

Endotracheal instillation of Infasurf once per week for three weeks

Also known as: Calfactant
A (two study drugs group)B (one study drug group)
PulmicortDRUG

Endotracheal instillation, once per week for three weeks

Also known as: Budesonide
A (two study drugs group)
ShamOTHER

None instilled through the endotracheal tube

Also known as: Air Sham
C (no study drug group)

Eligibility Criteria

Age24 Weeks - 28 Weeks
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Birth weight 501-1000 g and ≤ 28 weeks gestational age
  • Diagnosed as RDS requiring mechanical ventilation and surfactant therapy during the first 4 hours after birth
  • Still ventilated on day 5-9 of life.
  • An interval of at least 24 hours' duration between the last dose of indomethacin and the endotracheal instillation of study drug.

You may not qualify if:

  • Congenital or chromosomal anomalies
  • Occurrence of perinatal sepsis
  • Use of intravenous steroids \> 7 days

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

NICU-Pitt County Memorial Hospital

Greenville, North Carolina, 27834, United States

RECRUITING

MeSH Terms

Conditions

Bronchopulmonary Dysplasia

Interventions

calfactantBudesonidesalicylhydroxamic acid

Condition Hierarchy (Ancestors)

Ventilator-Induced Lung InjuryLung InjuryLung DiseasesRespiratory Tract DiseasesInfant, Premature, DiseasesInfant, Newborn, DiseasesCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

PregnenedionesPregnenesPregnanesSteroidsFused-Ring CompoundsPolycyclic Compounds

Study Officials

  • Waleed M Maamoun, MD

    Pitt County Memorial Hospital/Brody School of Medicine at East Carolina University

    PRINCIPAL INVESTIGATOR

  • James Cummings, MD

    Pitt County Memorial Hospital/Brody School of Medicine at East Carolina University

    STUDY DIRECTOR

  • Scott MacGilvray, MD

    Pitt County Memorial Hospital/Brody School of Medicine at East Carolina University

    STUDY CHAIR

  • Karl Kaminski, RRT-NPS

    Pitt County Memorial Hospital/Brody School of Medicine at East Carolina University

    STUDY CHAIR

Central Study Contacts

Waleed Maamoun, MD

CONTACT

1-252-744-3945maamounw@ecu.edu

James Cummings, MD

CONTACT

1-252-744-4787CummingsJ@ecu.edu

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

December 28, 2010

First Posted

December 29, 2010

Study Start

July 1, 2010

Primary Completion

June 1, 2012

Study Completion

December 1, 2013

Last Updated

December 29, 2010

Record last verified: 2010-07

Locations

US(1)