Frequency of Formula Change Prior to the Accurate Diagnosis of Pyloric Stenosis

Pyloric Stenosis Clinical Trial

Official title:

Frequency of Formula Change Prior to the Accurate Diagnosis of Pyloric Stenosis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00409734
• Other study ID #: 06/09/VA03
• Status: Completed
• Start date: September 28, 2006
• Est. completion date: December 8, 2008

Study information

• Verified date: August 2018
• Source: Maimonides Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The purpose of this study is to determine if there is an increase in the frequency of formula change in patients with pyloric sctenosis prior to being correctly diagnosed.

Description:

The study can be described as a prospective and retrospective study in which information will be gathered from questionnaires, analysis of medical records, and the information obtained from diagnostic procedures (i.e. Laboratory results, ultrasonography). The time of enrollment will be at the time of hospital admission for the study group and the control group. The length of time for which the patient will be involved with the study will coincide with the length of stay in the hospital. This will be a single center trial involving Maimonides Medical center. Approximately 50-100 subjects will be enrolled overall to give the study more credibility.

Methods and Procedures:

1. Study Participants: All patients admitted to Maimonides Medical Center with a diagnosis of pyloric stenosis two to nine weeks of age. Patients will be excluded from the study if there is a diagnosed milk allergy, history of prior abdominal surgery, or history of prematurity or metabolic disease. Controls will be made up of the same age range, with similar exclusion criteria, and will consist of patients admitted for other reasons than listed above, such as bronchiolitis and rule out sepsis.

2: Data: Data will be received through the completion of questionnaire.

3. Data collection and processing: Questionnaire responses will be analyzed and the responses will be statistically analyzed for correlation.

Benefits: Through participation in this study, patients may help future patients diagnosed with pyloric stenosis be brought to the attention of a medical professional.

Risks: With maintenance of confidentiality, risks to participants in this study are negligible.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: December 8, 2008
• Est. primary completion date: December 8, 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A to 9 Weeks

Eligibility

Inclusion Criteria:

• infants ages 2-9 weeks

Exclusion Criteria:

• infant not ages 2-9 weeks or patients with history of medical problems

Related Conditions & MeSH terms

• Constriction, Pathologic
• Gastric Outlet Obstruction
• Pyloric Stenosis

Intervention

Behavioral:
• Children with pyloric stenosis
Both cohorts' feeding habits will be observed and recorded for the purposes of comparison
• Children without pyloric stenosis
Both cohorts' feeding habits will be observed and recorded for the purposes of comparison

Locations

Country	Name	City	State
United States	Maimonides Medical Center	Brooklyn	New York

Sponsors (1)

Lead Sponsor	Collaborator
Maimonides Medical Center

Country where clinical trial is conducted

United States,