Pilot Trial of Surfactant Booster Prophylaxis For Ventilated Preterm Neonates

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

89 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-09-30

Study Completion Date

2007-11-30

Brief Summary

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A research study that will evaluate if giving surfactant medication to premature babies weighing \< 1250 gm at birth during the second and third weeks of life will help their lungs. We are enrolling those premature babies who continue to require the breathing tube and the mechanical ventilator at days 7-10 of life.

Detailed Description

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Pulmonary surfactant is required for normal lung function. Data from a previous study suggest that as many as 75% of chronically ventilated extremely low birthweight premature infants have at least one episode of surfactant dysfunction beyond the first week of life, as measured in vitro, associated with a low surfactant protein B content. Furthermore, episodes of surfactant dysfunction are significantly associated with clinically significant respiratory decompensations. We hypothesize that booster doses of surfactant given during the second and third week of life to extremely low birth weight premature infants requiring persistent intubation and mechanical ventilation will improve their respiratory status during the first 28 days of life. We propose to enroll premature infants \< 1250 gm birthweight, between days 7 and 10 of life who are intubated, and mechanically ventilated. Infants requiring persistent intubation and mechanical ventilation for respiratory support at 7-10 days of life will receive a total of 3 doses of Infasurf surfactant, 3 days apart, at the standard dose of 3 ml/kg. Primary outcome is the change in area under the respiratory severity score curve between days 7 and 28 of life. Total sample size is 88 infants, study duration is 36 months, and recruitment of study patients will occur at The Hospital of the University of Pennsylvania, in Philadelphia PA, Women and Children's Hospital in Buffalo, St. Louis Children's Hospital in St. Louis MO, Mercy Children's Hospital in Kansas City, Oakland Children's and Alta Bates Medical Center in Berkeley, CA and Long Island Jewish Medical Center, NY.

Conditions

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Respiratory Distress Syndrome Bronchopulmonary Dysplasia

Keywords

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Prematurity Lung Disease Hyaline Membrane Surfactant

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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Infasurf

Infasurf 3 cc/kg instilled via endotracheal tube, repeated 3 and 7 days later if infant stable and continues to meet criteria

Intervention Type DRUG

Other Intervention Names

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Infasurf (calfactant, manufactured for INOTherapeutics, Clinton NJ by ONY Inc., Amherst, NY)

Eligibility Criteria

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Inclusion Criteria

* Less than or equal to1250 gm birthweight
* Day 7-10 of life
* Intubated and mechanically ventilated at day 7-10 of life

Exclusion Criteria

* Infants intubated solely for apnea
* Serious congenital malformations
* Life expectancy \< 7 days from enrollment
* Pulmonary hemorrhage at time of enrollment
* Active air leak syndrome at time of enrollment
* Bilateral grade IV intracranial hemorrhage
* Postnatal systemic steroid therapy for lung disease

Note: Prior surfactant therapy at birth is neither an inclusion nor exclusion criterion.

Minimum Eligible Age

7 Days

Maximum Eligible Age

10 Days

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Principal Investigators

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Michael Posencheg, MD

Role: PRINCIPAL_INVESTIGATOR

University of Pennsylvania/Children's Hospital of Philadelphia

Roberta A Ballard, MD

Role: PRINCIPAL_INVESTIGATOR

University of California, San Francisco Medical Center

Countries

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United States

References

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Merrill JD, Ballard RA, Cnaan A, Hibbs AM, Godinez RI, Godinez MH, Truog WE, Ballard PL. Dysfunction of pulmonary surfactant in chronically ventilated premature infants. Pediatr Res. 2004 Dec;56(6):918-26. doi: 10.1203/01.PDR.0000145565.45490.D9. Epub 2004 Oct 20.

Reference Type BACKGROUND

PMID: 15496605 (View on PubMed)

Other Identifiers

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2004-9-3983

Identifier Type: -

Identifier Source: org_study_id