Evaluation of Infants Fed an Extensively Hydrolyzed Hypo Allergenic Infant Formula

March 2, 2021 updated by: Abbott Nutrition

Growth and Compliance of Infants Fed an Extensively Hydrolyzed Hypo Allergenic Infant Formula

The purpose of this study is to evaluate the growth and compliance of an intended use population of infants receiving an extensively hydrolyzed infant formula.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

320

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Adana, Turkey, 01150
        • Adana City Hospital
      • Afyon, Turkey, 03200
        • Afyon Kocatepe University Medical Faculty
      • Ankara, Turkey, 06590
        • Ankara University Medical Faculty
      • Ankara, Turkey, 06080
        • Ankara Dr. Sami Ulus Women and Child Disesase Research and Training Hospital B
      • Ankara, Turkey, 06100
        • Hacettepe Üniversitesi University Medical Faculty A
      • Ankara, Turkey, 06100
        • Hacettepe Üniversitesi University Medical Faculty B
      • Ankara, Turkey, 06110
        • Ankara Dışkapı Child Disease Hospital A
      • Ankara, Turkey, 06110
        • Ankara Dışkapı Child Disease Hospital B
      • Ankara, Turkey, 06230
        • Ankara Research and Training Hospital
      • Ankara, Turkey, 06370
        • Ankara Yıldırım Beyazıt University Yenimahalle Research and Training Hospital
      • Ankara, Turkey, 06500
        • Gazi Üniversitesi University Medical Faculty
      • Antalya, Turkey, 07070
        • Akdeniz University Medical Faculty A
      • Antalya, Turkey, 07070
        • Akdeniz University Medical Faculty B
      • Balıkesir, Turkey, 10145
        • Balıkesir University Research and Training Hospital
      • Bursa, Turkey, 16310
        • TC Sağlık Bilimleri University Bursa Yuksek Intisas Research and Training Hospital
      • Denizli, Turkey, 20070
        • Pamukkale University Medical Faculty A
      • Denizli, Turkey, 20070
        • Pamukkale University Medical Faculty B
      • Elazığ, Turkey, 23119
        • Fırat Üniversitesi University Medical Faculty
      • Erzurum, Turkey, 25070
        • Erzurum Research and Training Hospital
      • Gaziantep, Turkey, 27310
        • Gaziantep University Medical Faculty
      • Hatay, Turkey, 31001
        • Hatay State Hospital
      • Istanbul, Turkey, 34230
        • Istanbul Esenler Women and Children Diseases Hospital
      • Kocaeli, Turkey, 41380
        • Kocaeli Üniversitesi University Medical Faculty
      • Konya, Turkey, 42060
        • Konya Necmettin Erbakan University Medical Faculty
      • Konya, Turkey, 42080
        • Konya Başkent University Hospital
      • Konya, Turkey, 42130
        • Konya Selcuk University Medical Faculty
      • Kırıkkale, Turkey, 71450
        • Kırıkkale University Medical Faculty
      • Malatya, Turkey, 44280
        • İnönü Üniversitesi University Medical Faculty
      • Samsun, Turkey, 55040
        • Samsun Research and Training Hospital
      • Trabzon, Turkey, 61080
        • Karadeniz Teknik University Medical Faculty
      • Trabzon, Turkey, 61290
        • Trabzon Kanuni Research and Training Hospital
      • Zonguldak, Turkey, 67000
        • Zonguldak Bülent Ecevit University Research and Training Hospital
      • İstanbul, Turkey, 34093
        • İstanbul University İstanbul Medical School A
      • İstanbul, Turkey, 34098
        • İstanbul University Cerrahpaşa Medical School
      • İstanbul, Turkey, 34147
        • İstanbul Bakırköy Dr. Sadi Konuk Research and Training Hospital
      • İstanbul, Turkey, 34303
        • İstanbul Atakent Acıbadem Hospital
      • İstanbul, Turkey, 34303
        • İstanbul Kanuni Sultan Süleyman Research and Training Hospital A
      • İstanbul, Turkey, 34371
        • İstanbul Sisli Hamidiye Etfal Research and Training Hospital C
      • İstanbul, Turkey, 34371
        • İstanbul Şişli Hamidiye Etfal Research and Training Hospital A
      • İstanbul, Turkey, 34371
        • İstanbul Şişli Hamidiye Etfal Research and Training Hospital B
      • İstanbul, Turkey, 34384
        • İstanbul Okmeydanı Research and Training Hospital
      • İstanbul, Turkey, 34457
        • İstanbul Maslak Acıbadem Hospital
      • İstanbul, Turkey, 34662
        • İstanbul Altunizade Acıbadem Hospital
      • İstanbul, Turkey, 34722
        • İstanbul Göztepe Research and Training Hospital
      • İstanbul, Turkey, 34764
        • İstanbul Ümraniye Research and Training Hospital A
      • İstanbul, Turkey, 34764
        • İstanbul Ümraniye Research and Training Hospital B

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 second to 5 months (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Subjects will be enrolled from outpatient clinics and physician offices.

Description

Inclusion Criteria:

  • Infant is experiencing persistent feeding intolerance or allergy and diagnosed wtih Cow's Milk Protein Allergy (CMPA) or other condition where an extensively hydrolyzed formula is deemed appropriate by their healthcare professional
  • Infants using OTC medications, home remedies, herbal preparations or rehydration fluids that might affect GI tolerance
  • Parent(s) of infants enrolled on prescription medications, OTC medications, home remedies, herbal preparations or rehydration fluids directed by their healthcare professional, confirm their intention to continue their use during the study until directed by their healthcare professional to discontinue.
  • Infant is not receiving steroids.
  • Parent(s) confirm their intention to feed their infant the study product as the sole source of nutrition for the duration of the study
  • Parent(s) confirm their intention not to administer solid foods or juices to their infant from enrollment through the duration of the study
  • Parent(s) confirm their intention not to administer vitamin or mineral supplements to their infant from enrollment through the duration of the study
  • Infant's parent(s) or a LAR has voluntarily signed and dated an informed consent form (ICF), approved by an Independent Ethics Committee/Institutional Review Board (IEC/IRB)

Exclusion Criteria:

  • Participation in another study that has not been approved as a concomitant study by AN

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Weight
Time Frame: Baseline to Study Day 30
Measured in Kg
Baseline to Study Day 30

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Formula Intake
Time Frame: Baseline to Study Day 30
Parent completed diary
Baseline to Study Day 30

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Abbott Nutrition

Investigators

  • Study Chair: Aysugul Alptekin, MD, Abbott Turkey

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 31, 2018

Primary Completion (Actual)

March 27, 2020

Study Completion (Actual)

March 27, 2020

Study Registration Dates

First Submitted

July 13, 2018

First Submitted That Met QC Criteria

July 13, 2018

First Posted (Actual)

July 24, 2018

Study Record Updates

Last Update Posted (Actual)

March 3, 2021

Last Update Submitted That Met QC Criteria

March 2, 2021

Last Verified

March 1, 2021

More Information

Terms related to this study

Other Study ID Numbers

  • DA16

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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