Evaluation of Infants Fed an Extensively Hydrolyzed Hypo Allergenic Infant Formula

NCT03597113 | Completed

• 1 other identifier: DA16
• Study Type: observational
• Target: 320
• Locations: 1 country
• Sites: 46

Brief Summary

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.

Conditions

Gastrointestinal Tolerance

Outcome Measures

Primary Outcomes (1)

• Weight

  Measured in Kg

  Baseline to Study Day 30

Secondary Outcomes (1)

• Formula Intake

  Baseline to Study Day 30

Eligibility Criteria

• Age: 0 Days - 180 Days
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

Subjects will be enrolled from outpatient clinics and physician offices.

You may qualify if:

• 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)

You may not qualify if:

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

Sponsors & Collaborators

• Abbott Nutrition: lead

Study Sites (46)

Adana City Hospital

Adana, 01150, Turkey (Türkiye)

Location

Afyon Kocatepe University Medical Faculty

Afyonkarahisar, 03200, Turkey (Türkiye)

Location

Ankara Dr. Sami Ulus Women and Child Disesase Research and Training Hospital B

Ankara, 06080, Turkey (Türkiye)

Location

Hacettepe Üniversitesi University Medical Faculty A

Ankara, 06100, Turkey (Türkiye)

Location

Hacettepe Üniversitesi University Medical Faculty B

Ankara, 06100, Turkey (Türkiye)

Location

Ankara Dışkapı Child Disease Hospital A

Ankara, 06110, Turkey (Türkiye)

Location

Ankara Dışkapı Child Disease Hospital B

Ankara, 06110, Turkey (Türkiye)

Location

Ankara Research and Training Hospital

Ankara, 06230, Turkey (Türkiye)

Location

Ankara Yıldırım Beyazıt University Yenimahalle Research and Training Hospital

Ankara, 06370, Turkey (Türkiye)

Location

Gazi Üniversitesi University Medical Faculty

Ankara, 06500, Turkey (Türkiye)

Location

Ankara University Medical Faculty

Ankara, 06590, Turkey (Türkiye)

Location

Akdeniz University Medical Faculty A

Antalya, 07070, Turkey (Türkiye)

Location

Akdeniz University Medical Faculty B

Antalya, 07070, Turkey (Türkiye)

Location

Balıkesir University Research and Training Hospital

Balıkesir, 10145, Turkey (Türkiye)

Location

TC Sağlık Bilimleri University Bursa Yuksek Intisas Research and Training Hospital

Bursa, 16310, Turkey (Türkiye)

Location

Pamukkale University Medical Faculty A

Denizli, 20070, Turkey (Türkiye)

Location

Pamukkale University Medical Faculty B

Denizli, 20070, Turkey (Türkiye)

Location

Fırat Üniversitesi University Medical Faculty

Elâzığ, 23119, Turkey (Türkiye)

Location

Erzurum Research and Training Hospital

Erzurum, 25070, Turkey (Türkiye)

Location

Gaziantep University Medical Faculty

Gaziantep, 27310, Turkey (Türkiye)

Location

Hatay State Hospital

Hatay, 31001, Turkey (Türkiye)

Location

İstanbul University İstanbul Medical School A

Istanbul, 34093, Turkey (Türkiye)

Location

İstanbul University Cerrahpaşa Medical School

Istanbul, 34098, Turkey (Türkiye)

Location

İstanbul Bakırköy Dr. Sadi Konuk Research and Training Hospital

Istanbul, 34147, Turkey (Türkiye)

Location

Istanbul Esenler Women and Children Diseases Hospital

Istanbul, 34230, Turkey (Türkiye)

Location

İstanbul Atakent Acıbadem Hospital

Istanbul, 34303, Turkey (Türkiye)

Location

İstanbul Kanuni Sultan Süleyman Research and Training Hospital A

Istanbul, 34303, Turkey (Türkiye)

Location

İstanbul Sisli Hamidiye Etfal Research and Training Hospital C

Istanbul, 34371, Turkey (Türkiye)

Location

İstanbul Şişli Hamidiye Etfal Research and Training Hospital A

Istanbul, 34371, Turkey (Türkiye)

Location

İstanbul Şişli Hamidiye Etfal Research and Training Hospital B

Istanbul, 34371, Turkey (Türkiye)

Location

İstanbul Okmeydanı Research and Training Hospital

Istanbul, 34384, Turkey (Türkiye)

Location

İstanbul Maslak Acıbadem Hospital

Istanbul, 34457, Turkey (Türkiye)

Location

İstanbul Altunizade Acıbadem Hospital

Istanbul, 34662, Turkey (Türkiye)

Location

İstanbul Göztepe Research and Training Hospital

Istanbul, 34722, Turkey (Türkiye)

Location

İstanbul Ümraniye Research and Training Hospital A

Istanbul, 34764, Turkey (Türkiye)

Location

İstanbul Ümraniye Research and Training Hospital B

Istanbul, 34764, Turkey (Türkiye)

Location

Kocaeli Üniversitesi University Medical Faculty

Kocaeli, 41380, Turkey (Türkiye)

Location

Konya Necmettin Erbakan University Medical Faculty

Konya, 42060, Turkey (Türkiye)

Location

Konya Başkent University Hospital

Konya, 42080, Turkey (Türkiye)

Location

Konya Selçuk University Medical Faculty

Konya, 42130, Turkey (Türkiye)

Location

Kırıkkale University Medical Faculty

Kırıkkale, 71450, Turkey (Türkiye)

Location

İnönü Üniversitesi University Medical Faculty

Malatya, 44280, Turkey (Türkiye)

Location

Samsun Research and Training Hospital

Samsun, 55040, Turkey (Türkiye)

Location

Karadeniz Teknik University Medical Faculty

Trabzon, 61080, Turkey (Türkiye)

Location

Trabzon Kanuni Research and Training Hospital

Trabzon, 61290, Turkey (Türkiye)

Location

Zonguldak Bülent Ecevit University Research and Training Hospital

Zonguldak, 67000, Turkey (Türkiye)

Location

Study Officials

• Aysugul Alptekin, MD

  Abbott Turkey

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 13, 2018
• First Posted: July 24, 2018
• Study Start: January 31, 2018
• Primary Completion: March 27, 2020
• Study Completion: March 27, 2020
• Last Updated: March 3, 2021

Record last verified: 2021-03

Locations

TU (46)