CClinicalTrials.gg
CompletedNCT00409734Updated Aug 17, 2018

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

An observational study in Pyloric Stenosis, sponsored by Maimonides Medical Center. Completed at 1 site in United States. Open to participants aged 2 Weeks to 9 Weeks, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-08-17.

Sponsored by Maimonides Medical Center · Observational

Study type
Observational
Model
Case-control
Time perspective
Retrospective
Enrollment
20
Ages
2 Weeks to 9 Weeks
Sex
All
01

Study 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.

Read the 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.

  1. 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.

02

Conditions studied

  • Pyloric Stenosis

Keywords

  • pyloric
  • stenosis
03

In context

Pyloric Stenosis

29 studies on the registry are indexed under Pyloric Stenosis; 1 is open to participants now.

Browse Pyloric Stenosis studies →

Lead sponsor

Maimonides Medical Center is the lead sponsor of 50 studies on the registry; 1 is open to participants now.

Of its 7 completed or terminated interventional studies of FDA-regulated products, 6 (86%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
2 Weeks to 9 Weeks
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

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

Inclusion criteria

  • infants ages 2-9 weeks

Exclusion criteria

Exclusion Criteria:

  • infant not ages 2-9 weeks or patients with history of medical problems
05

Study design

Observational model
Case-control
Time perspective
Retrospective
Enrollment
20 participants (actual)

Groups and cohorts

  • 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

  • BehavioralChildren with pyloric stenosis

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

  • BehavioralChildren without pyloric stenosis

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

06

Study locations

1 site
  • Maimonides Medical Center
    Brooklyn, New York 11219, United States
07

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 17, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
08

Registry details

Key details

Study ID
NCT00409734
Lead sponsor
Maimonides Medical Center
Responsible party
Sponsor
First posted
Dec 11, 2006
Start date
Sep 28, 2006
Primary completion
Dec 8, 2008
Completion
Dec 8, 2008
Last update
Aug 17, 2018

Study contacts

Beth Loveridge-Lenza, DO
principal investigator · Maimonides Medical Center
Maya Greenberg, DO
principal investigator · Maimonides Medical Center
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Aug 2018. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion