Frequency of Formula Change Prior to the Accurate Diagnos... | NCT00409734

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

NCT00409734

Sponsor

Maimonides Medical Center

Status

Completed

Last Update Posted

Aug 17, 2018Actual

Enrollment

20Actual

Phase

Not provided

Conditions

Pyloric Stenosis

Interventions

Children with pyloric stenosis
Children without pyloric stenosis

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2018

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 28, 2006Actual

Primary Completion Date

Dec 8, 2008Actual

Completion Date

Dec 8, 2008Actual

First Submitted Date

Dec 8, 2006

First Submission Date that Met QC Criteria

Dec 8, 2006

First Posted Date

Dec 11, 2006Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 15, 2018

Last Update Posted Date

Aug 17, 2018Actual

Description Module

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

20Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Children with pyloric stenosis		Male or female children age two to nine weeks with history of vomiting and feeding intolerance, and abdominal sonogram showing presence of pyloric stenosis	Behavioral: Children with pyloric stenosis
Children without pyloric stenosis		Male or female children age two to nine weeks without pyloric stenosis admitted to the hospital for other reasons	Behavioral: Children without pyloric stenosis

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Children with pyloric stenosis	Behavioral	Both cohorts' feeding habits will be observed and recorded for the purposes of comparison	Children with pyloric stenosis

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

infants ages 2-9 weeks

Exclusion Criteria:

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

2 Weeks

Maximum Age

9 Weeks

Standard Ages

Child

Study Population

Male and female children age 2 weeks to 9 weeks, either with pyloric stenosis or without

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Beth Loveridge-Lenza, DO	Maimonides Medical Center	Principal Investigator
Maya Greenberg, DO	Maimonides Medical Center	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Maimonides Medical Center		Brooklyn	New York	11219	United States

Condition Browse Module

MeSH Terms

ID	Term
D011707	Pyloric Stenosis
D003251	Constriction, Pathologic

Ancestor Terms

ID	Term
D017219	Gastric Outlet Obstruction
D013272	Stomach Diseases
D005767	Gastrointestinal Diseases
D004066	Digestive System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided