Skip to main content
OpenTrials
Completed

NCT Number: NCT01601886

Delivery Room Practice Change Following the Initiation of the NICHD SUPPORT Trial

This study was designed to analyze whether initiation of the NICHD Neonatal Research Network SUPPORT trial was followed by a change in frequency of endotracheal intubation the delivery room in non-participants and whether these changes were associated with changes in management and outcomes.

The investigators hypothesized that the investigators would observe following the initiation of the SUPPORT trial a 33% reduction in the rate of intubation in the delivery room among non-participants preterm infants at Parkland Memorial Hospital.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Preterm Birth Female Urogenital Diseases and Pregnancy Complications Obstetric Labor Complications Obstetric Labor, Premature Pregnancy Complications Premature Birth Urogenital Diseases

Age range

24 week–35 week

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Texas Southwestern

Dallas, Texas, 75390-9063, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • All babies born at Parkland Memorial Hospital with gestational age at least 24 weeks and less than 35 weeks between 01/2003 and 06/2010

Exclusion criteria

  • Infants receiving comfort care
  • Those with major congenital anomalies
  • Those enrolled in the SUPPORT trial

Treatment and study plan

Primary outcomes

  1. Endotracheal intubation in the delivery room

    Time frame: In the delivery room (1 day)

    Frequency of endotracheal intubation in the delivery room

Secondary outcomes

  1. Continuous positive airway pressure in the delivery room

    Time frame: In the delivery room (1 day)

    Frequency of continuous positive airway pressure in the delivery room

  2. Endotracheal intubation in the first four hours after admission

    Time frame: First four hours after admission

    Frequency of endotracheal intubation in the first fours after admission to the neonatal intensive care unit

  3. Endotracheal intubation until four hours after admission

    Time frame: Between birth and 4 hours after admission

    Frequency of endotracheal intubation between birth and four hours after admission in the neonatal intensive care unit

  4. Admninistration of surfactant

    Time frame: Any time between birth and 2 days of age

    Frequency of admninistration of surfactant any time between birth and 2 days of age

  5. Pneumothorax

    Time frame: Any time before discharge or transfer or 12 months of age (whichever comes first)

    Pneumothorax any time before discharge or transfer or 12 months of age (whichever comes first)

  6. Bronchopulmonary dysplasia

    Time frame: 28 days

    Chronic changes on chest radiograph and oxygen requirement (fractional inspiratory concentration of oxygen greater than 0.21) for at least 28 days

  7. Necrotizing enterocolitis

    Time frame: Any time before discharge or transfer or 12 months of age (whichever comes first)

    Necrotizing enterocolitis (at least stage II, modified Bell's classification) any time before discharge or transfer or 12 months of age (whichever comes first)

  8. Duration of mechanical ventilation

    Time frame: Until discharge or transfer or 12 months of age (whichever comes first)

    Duration of invasive mechanical ventilation until discharge or transfer or or 12 months of age (whichever comes first)

  9. Maximum oxygen concentration

    Time frame: Until discharge or transfer or 12 months of age (whichever comes first)

    Maximum inspiratory oxygen concentration until discharge or transfer or 12 months of age (whichever comes first)

  10. Severe retinopathy of prematurity

    Time frame: Until discharge or transfer or 12 months of age (whichever comes first)

    Severe retinopathy of prematurity (at least stage III, international classification) until discharge or transfer or 12 months of age (whichever comes first)

  11. Mortality

    Time frame: Until discharge or transfer or 12 months of age (whichever comes first)

    Mortality until discharge or transfer or 12 months of age (whichever comes first)

  12. Severe brain lesion on imaging

    Time frame: Any time before discharge or transfer or 12 months of age (whichever comes first)

    Cystic periventricular leukomalacia or grade III or IV intraventricular/ periventricular hemorrhage detected by ultrasonogram any time before discharge or transfer or 12 months of age (whichever comes first)

Sponsors and collaborators

Lead sponsor

Luc Brion

Other

Collaborators

  • University of Texas Southwestern Medical Center

Registry information

Important dates

Study start
2008
Primary completion
2011
Study completion
2012
First posted
May 18, 2012
Registry last updated
May 18, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.