NCT00486850

Brief Summary

Title of Study: A Prospective, Randomized, Multicenter Trial Comparing Synchronized Intermittent Mandatory Ventilation (SIMV) vs. Early Extubation to Nasal Intermittent Positive Pressure Ventilation (NIPPV) after Surfactant Treatment in Preterm Infants with Respiratory Distress Treatment Period (Planned): 7 days Objectives: To compare the impact of early extubation \[within 120 minutes of birth to Nasal Intermittent Positive Pressure Ventilation (NIPPV group) vs. Synchronized Intermittent Mandatory Ventilation (SIMV group) on the incidence of mechanical ventilation via endotracheal tube at 7 days of age in 26 to 29 + 6 weeks gestation premature infants with respiratory distress treated with intratracheal Curosurf (poractant alpha) within 60 minutes of birth. Secondary objectives include evaluation of overall clinical outcomes at 7 days, 28 days, and 36 weeks postmenstrual age (PMA) and/or at discharge, complications, safety, and adverse events. Number of Subjects: 110

Trial Health

87
On Track

Trial Health Score

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

Enrollment
110

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Oct 2006

Typical duration for phase_4

Geographic Reach
1 country

4 active sites

Status
completed

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

October 1, 2006

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

June 13, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 15, 2007

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2008

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2009

Completed
Last Updated

July 10, 2009

Status Verified

February 1, 2009

Enrollment Period

2.1 years

First QC Date

June 13, 2007

Last Update Submit

July 9, 2009

Conditions

Respiratory Distress Syndrome, Newborn

Keywords

RDSPretermSIMVNIPPV

Outcome Measures

Primary Outcomes (1)

  • Incidence of Mechanical Ventilation via endotracheal tube at 7 days of age

    At 7 days of age

Secondary Outcomes (1)

  • Overall clinical outcomes at 7 days, 28 days, and 36 weeks postmenstrual age

    At 7 days, 28 days and at 36 weeks postmenstraul age

Interventions

Extubation to Nasal IPPVOTHER

Comparison of extubation to NIPPV versus NCPAP

Also known as: NIPPV, SIMV

Eligibility Criteria

Age10 Minutes - 120 Minutes
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Estimated gestational age 26 to 29 + 6 weeks inclusive;
  • Inborn;
  • Birth Weight: ≥ 600 grams;
  • Required endotracheal intubation for respiratory distress;
  • Has received one dose of poractant alfa 200mg/kg within 60 minutes of birth;
  • No known lethal congenital anomaly or genetic syndromes;
  • No known lung maturity; and
  • Signed parental informed consent

You may not qualify if:

  • Gestational age \< 26 weeks or ≥ 30 weeks;
  • Birth weight less than 600 grams;
  • Apgar score of 0 at one minute of age; and
  • Lethal congenital anomaly or genetic syndrome identified antenatally or within 60 minutes of birth

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Women's and Children's Hospital, Room l-919, 1240, N.Mission Road

Los Angeles, California, 90033, United States

Location

Sharp Mary Birch Hospital for Women

San Diego, California, 62123, United States

Location

Medical College of Georgia

Augusta, Georgia, 30912, United States

Location

Children's Hospital, OUMC

Oklahoma City, Oklahoma, 73190, United States

Location

MeSH Terms

Conditions

Respiratory Distress Syndrome, NewbornPremature Birth

Condition Hierarchy (Ancestors)

Respiratory Distress SyndromeLung DiseasesRespiratory Tract DiseasesRespiration DisordersInfant, Premature, DiseasesInfant, Newborn, DiseasesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesObstetric Labor, PrematureObstetric Labor ComplicationsPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital Diseases

Study Officials

  • Rangasamy Ramanathan, MD

    University of Southern California

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

June 13, 2007

First Posted

June 15, 2007

Study Start

October 1, 2006

Primary Completion

November 1, 2008

Study Completion

January 1, 2009

Last Updated

July 10, 2009

Record last verified: 2009-02

Locations

US(4)