Efficacy and Safety of Gastric Suctioning During Neonatal Resuscitation
The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2008 by University of Iowa.
Recruitment status was Not yet recruiting
Recruitment status was Not yet recruiting
Sponsor:
University of Iowa
Collaborator:
Thrasher Research Fund
Information provided by:
University of Iowa
ClinicalTrials.gov Identifier:
NCT00729989
First received: August 5, 2008
Last updated: August 7, 2008
Last verified: August 2008
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Purpose
The stomach of the newborn baby is often emptied soon after birth to prevent breathing problems (respiratory distress). Babies born with meconium-stained amniotic fluid and those with increased secretions associated with birth by C-section are thought to be at particular risk of breathing problems during the first minutes of life. Emptying the stomach by sucking out all its contents (gastric suctioning) is alleged to lessen the risk of aspiration and improve respiratory distress. This study will evaluate the usefulness of gastric suctioning during neonatal resuscitation.
| Condition | Intervention |
|---|---|
|
Respiratory Distress |
Procedure: Gastric suctioning |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Efficacy and Safety of Gastric Suctioning During Neonatal Resuscitation- A Randomized Clinical Trial |
Further study details as provided by University of Iowa:
Primary Outcome Measures:
- Respiratory Distress [ Time Frame: Birth ] [ Designated as safety issue: Yes ]
Secondary Outcome Measures:
- Apgar scores [ Time Frame: Birth ] [ Designated as safety issue: No ]
- Successful feeding/weight gain [ Time Frame: Birth ] [ Designated as safety issue: No ]
- Hospital length of stay [ Time Frame: Birth ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 5000 |
| Study Start Date: | August 2008 |
| Estimated Study Completion Date: | June 2010 |
| Estimated Primary Completion Date: | June 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| No Intervention: 1 | |
| Experimental: 2 |
Procedure: Gastric suctioning
The stomach will be suctioned shortly following birth with an orogastric tube
|
Eligibility| Ages Eligible for Study: | up to 7 Days |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Criteria
Inclusion Criteria:
- Term infant with meconium stained amniotic fluid or born by C-section
Exclusion Criteria:
- Prematurity
- Congenital Abnormality
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00729989
Contacts
| Contact: Benjamin T Stevens, MD | 319-384-6576 | benjamin-stevens@uiowa.edu |
Locations
| United States, Iowa | |
| University of Iowa Children's Hospital | Not yet recruiting |
| Iowa City, Iowa, United States, 52242 | |
| Contact: Benjamin T Stevens, MD 319-384-6576 benjamin-stevens@uiowa.edu | |
| Principal Investigator: Benjamin T Stevens, MD | |
Sponsors and Collaborators
University of Iowa
Thrasher Research Fund
More Information
No publications provided
| Responsible Party: | Benjamin T. Stevens, University of Iowa |
| ClinicalTrials.gov Identifier: | NCT00729989 History of Changes |
| Other Study ID Numbers: | 200804774 |
| Study First Received: | August 5, 2008 |
| Last Updated: | August 7, 2008 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by University of Iowa:
|
Meconium Aspiration Respiratory Distress Meconium Stained Amniotic Fluid |
ClinicalTrials.gov processed this record on May 23, 2013