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Zinc and Copper Absorption in Neonates With Bilious Losses

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Steve Abrams, MD, Baylor College of Medicine
ClinicalTrials.gov Identifier:
NCT00738283
First received: August 18, 2008
Last updated: July 23, 2015
Last verified: July 2015
Results First Received: September 24, 2012  
Study Type: Observational
Study Design: Observational Model: Cohort;   Time Perspective: Prospective
Condition: Ileostomy

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Subjects were recruited in the Neonatal Intensive Care Unit at Texas Children's Hospital between September 2008 and May 2010.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Observational Group Infants admitted to the NICU of Texas Children’s Hospital, Houston, TX who had a jejunostomy or ileostomy were recruited for the study. Neonates were enrolled if they had a jejunostomy or ileostomy and if their birth weight was > 500 grams. Infants were excluded from the study if they had any other major congenital anomalies (including congenital heart disease and cystic fibrosis), or if they were believed to be unlikely to survive to hospital discharge based on their cardiopulmonary disease.

Participant Flow:   Overall Study
    Observational Group  
STARTED     17  
COMPLETED     13  
NOT COMPLETED     4  
Death                 1  
Transfer to another facility                 2  
Discharge home prior to end of study                 1  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Observational Group Infants admitted to the NICU of Texas Children’s Hospital, Houston, TX who had a jejunostomy or ileostomy were recruited for the study. Neonates were enrolled if they had a jejunostomy or ileostomy and if their birth weight was > 500 grams. Infants were excluded from the study if they had any other major congenital anomalies (including congenital heart disease and cystic fibrosis), or if they were believed to be unlikely to survive to hospital discharge based on their cardiopulmonary disease.

Baseline Measures
    Observational Group  
Number of Participants  
[units: participants]
  17  
Age  
[units: participants]
 
<=18 years     17  
Between 18 and 65 years     0  
>=65 years     0  
Age  
[units: days of life]
Mean (Standard Deviation)
  44  (23)  
Gender  
[units: participants]
 
Female     11  
Male     6  
Region of Enrollment  
[units: participants]
 
United States     17  



  Outcome Measures

1.  Primary:   Zinc Absorption   [ Time Frame: 96 hours after single feed infusion ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
Only 10 infants achieved a majority of enteral feeds with the ostomy in place, of which only 7 were fully enterally fed at the time of the study. This is a mixed group, but nonetheless representative of infants with small intestinal ostomies.


  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Steven A. Abrams, MD
Organization: Baylor College of Medicine
phone: 713-798-7164
e-mail: sabrams@bcm.edu


Publications:

Responsible Party: Steve Abrams, MD, Baylor College of Medicine
ClinicalTrials.gov Identifier: NCT00738283     History of Changes
Other Study ID Numbers: H-23224
Study First Received: August 18, 2008
Results First Received: September 24, 2012
Last Updated: July 23, 2015
Health Authority: United States: Institutional Review Board