Synchronized Intermittent Mandatory Ventilation (SIMV) Versus Nasal Intermittent Positive Pressure Ventilation (NIPPV) In Preterm Infants With Respiratory Distress
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ClinicalTrials.gov Identifier: NCT00486850 |
Recruitment Status :
Completed
First Posted : June 15, 2007
Last Update Posted : July 10, 2009
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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
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Respiratory Distress Syndrome, Newborn | Other: Extubation to Nasal IPPV | Phase 4 |

Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 110 participants |
Allocation: | Randomized |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Synchronized Intermittent Mandatory Ventilation (SIMV) Versus Nasal Intermittent Positive Pressure Ventilation (NIPPV) In Preterm Infants With Respiratory Distress |
Study Start Date : | October 2006 |
Actual Primary Completion Date : | November 2008 |
Actual Study Completion Date : | January 2009 |

- Other: Extubation to Nasal IPPV
Comparison of extubation to NIPPV versus NCPAPOther Names:
- NIPPV
- SIMV
- Incidence of Mechanical Ventilation via endotracheal tube at 7 days of age [ Time Frame: At 7 days of age ]
- Overall clinical outcomes at 7 days, 28 days, and 36 weeks postmenstrual age [ Time Frame: At 7 days, 28 days and at 36 weeks postmenstraul age ]

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Ages Eligible for Study: | up to 120 Minutes (Child) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00486850
United States, California | |
Women's and Children's Hospital, Room l-919, 1240, N.Mission Road | |
Los Angeles, California, United States, 90033 | |
Sharp Mary Birch Hospital for Women | |
San Diego, California, United States, 62123 | |
United States, Georgia | |
Medical College of Georgia | |
Augusta, Georgia, United States, 30912 | |
United States, Oklahoma | |
Children's Hospital, OUMC | |
Oklahoma, Oklahoma, United States, 73190 |
Principal Investigator: | Rangasamy Ramanathan, MD | University of Southern California |
Responsible Party: | Rangasamy Ramanathan, MD., University of Southern California |
ClinicalTrials.gov Identifier: | NCT00486850 |
Other Study ID Numbers: |
SIMV versus NIPPV Trial |
First Posted: | June 15, 2007 Key Record Dates |
Last Update Posted: | July 10, 2009 |
Last Verified: | February 2009 |
RDS Preterm SIMV NIPPV |
Respiratory Distress Syndrome, Newborn Respiratory Distress Syndrome, Adult Lung Diseases Respiratory Tract Diseases |
Respiration Disorders Infant, Premature, Diseases Infant, Newborn, Diseases |