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

Maimonides Medical Center

Status: Completed

Conditions: Pyloric Stenosis

Treatments: Behavioral: Children without pyloric stenosis; Behavioral: Children with pyloric stenosis

Study type: Observational

Funder types: Other

Identifiers

NCT00409734

06/09/VA03

Details and patient eligibility

About

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.

Full 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.

Enrollment: 20 patients

Sex: All

Ages: 2 to 9 weeks old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• infants ages 2-9 weeks

Exclusion criteria

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

Trial design

20 participants in 2 patient groups

Children with pyloric stenosis

Description:

Male or female children age two to nine weeks with history of vomiting and feeding intolerance, and abdominal sonogram showing presence of pyloric stenosis

Treatment:

Behavioral: Children with pyloric stenosis

Children without pyloric stenosis

Description:

Male or female children age two to nine weeks without pyloric stenosis admitted to the hospital for other reasons

Treatment:

Behavioral: Children without pyloric stenosis