Ignite Creation Date:
2025-12-25 @ 2:31 AM
Ignite Modification Date:
2025-12-26 @ 1:07 AM
Study NCT ID:
NCT00409734
Status:
COMPLETED
Last Update Posted:
2018-08-17
First Post:
2006-12-08
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Frequency of Formula Change Prior to the Accurate Diagnosis of Pyloric Stenosis
Sponsor:
Maimonides Medical Center
Organization:
Study Overview
Official Title:
Frequency of Formula Change Prior to the Accurate Diagnosis of Pyloric Stenosis
Status:
COMPLETED
Status Verified Date:
2018-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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.
Detailed 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.
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.
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?: