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Completed

NCT Number: NCT00409734

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

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.

Completed

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Key information

Age range

2 week–9 week

Sex eligibility

All sexes

Study type

Observational

Primary location

Maimonides Medical Center

Brooklyn, New York, 11219, United States

About this study

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:

  • 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.

  • 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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • infants ages 2-9 weeks

Exclusion criteria

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

Treatment and study plan

Children with pyloric stenosis

Behavioral

Both cohorts' feeding habits will be observed and recorded for the purposes of comparison

Children without pyloric stenosis

Behavioral

Both cohorts' feeding habits will be observed and recorded for the purposes of comparison

Sponsors and collaborators

Lead sponsor

Maimonides Medical Center

Other

Registry information

Important dates

Study start
2006
Primary completion
2008
Study completion
2008
First posted
Dec 11, 2006
Registry last updated
Aug 17, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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