Evaluation of Infants Fed an Extensively Hydrolyzed Hypo Allergenic Infant Formula

Completed

• Conditions: Gastrointestinal Tolerance

• Registration Number: NCT03597113
• Lead Sponsor: Abbott Nutrition

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2018-01-31
• Study First Submitted: 2018-07-13
• Study First Submitted QC: 2018-07-13
• Study First Posted: 2018-07-24
• Primary Completion: 2020-03-27
• Study Completion: 2020-03-27
• Status Verified: 2021-03
• Last Update Submitted: 2021-03-02
• Last Update Posted: 2021-03-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 320

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Weight	Baseline to Study Day 30	Measured in Kg

Secondary Outcome Measures

Name	Time	Method
Formula Intake	Baseline to Study Day 30	Parent completed diary

Trial Locations

Locations (46)

Ankara University Medical Faculty; 🇹🇷 Ankara, Turkey

Akdeniz University Medical Faculty A; 🇹🇷 Antalya, Turkey

Ankara Dr. Sami Ulus Women and Child Disesase Research and Training Hospital B; 🇹🇷 Ankara, Turkey

Ankara Dışkapı Child Disease Hospital B; 🇹🇷 Ankara, Turkey

Adana City Hospital; 🇹🇷 Adana, Turkey

Afyon Kocatepe University Medical Faculty; 🇹🇷 Afyon, Turkey

Hacettepe Üniversitesi University Medical Faculty A; 🇹🇷 Ankara, Turkey

Ankara Dışkapı Child Disease Hospital A; 🇹🇷 Ankara, Turkey

Gazi Üniversitesi University Medical Faculty; 🇹🇷 Ankara, Turkey

Erzurum Research and Training Hospital; 🇹🇷 Erzurum, Turkey

Ankara Research and Training Hospital; 🇹🇷 Ankara, Turkey

Akdeniz University Medical Faculty B; 🇹🇷 Antalya, Turkey

TC Sağlık Bilimleri University Bursa Yuksek Intisas Research and Training Hospital; 🇹🇷 Bursa, Turkey

Pamukkale University Medical Faculty A; 🇹🇷 Denizli, Turkey

Pamukkale University Medical Faculty B; 🇹🇷 Denizli, Turkey

Hatay State Hospital; 🇹🇷 Hatay, Turkey

İstanbul University İstanbul Medical School A; 🇹🇷 İstanbul, Turkey

Trabzon Kanuni Research and Training Hospital; 🇹🇷 Trabzon, Turkey

Zonguldak Bülent Ecevit University Research and Training Hospital; 🇹🇷 Zonguldak, Turkey

İstanbul Ümraniye Research and Training Hospital A; 🇹🇷 İstanbul, Turkey

İstanbul Ümraniye Research and Training Hospital B; 🇹🇷 İstanbul, Turkey

Kocaeli Üniversitesi University Medical Faculty; 🇹🇷 Kocaeli, Turkey

Konya Başkent University Hospital; 🇹🇷 Konya, Turkey

Konya Selçuk University Medical Faculty; 🇹🇷 Konya, Turkey

Hacettepe Üniversitesi University Medical Faculty B; 🇹🇷 Ankara, Turkey

Ankara Yıldırım Beyazıt University Yenimahalle Research and Training Hospital; 🇹🇷 Ankara, Turkey

Balıkesir University Research and Training Hospital; 🇹🇷 Balıkesir, Turkey

Fırat Üniversitesi University Medical Faculty; 🇹🇷 Elazığ, Turkey

Gaziantep University Medical Faculty; 🇹🇷 Gaziantep, Turkey

İstanbul University Cerrahpaşa Medical School; 🇹🇷 İstanbul, Turkey

İstanbul Bakırköy Dr. Sadi Konuk Research and Training Hospital; 🇹🇷 İstanbul, Turkey

Istanbul Esenler Women and Children Diseases Hospital; 🇹🇷 Istanbul, Turkey

İstanbul Atakent Acıbadem Hospital; 🇹🇷 İstanbul, Turkey

İstanbul Kanuni Sultan Süleyman Research and Training Hospital A; 🇹🇷 İstanbul, Turkey

İstanbul Sisli Hamidiye Etfal Research and Training Hospital C; 🇹🇷 İstanbul, Turkey

İstanbul Şişli Hamidiye Etfal Research and Training Hospital A; 🇹🇷 İstanbul, Turkey

İstanbul Şişli Hamidiye Etfal Research and Training Hospital B; 🇹🇷 İstanbul, Turkey

İstanbul Okmeydanı Research and Training Hospital; 🇹🇷 İstanbul, Turkey

İstanbul Maslak Acıbadem Hospital; 🇹🇷 İstanbul, Turkey

İstanbul Altunizade Acıbadem Hospital; 🇹🇷 İstanbul, Turkey

İstanbul Göztepe Research and Training Hospital; 🇹🇷 İstanbul, Turkey

Konya Necmettin Erbakan University Medical Faculty; 🇹🇷 Konya, Turkey

Kırıkkale University Medical Faculty; 🇹🇷 Kırıkkale, Turkey

İnönü Üniversitesi University Medical Faculty; 🇹🇷 Malatya, Turkey

Samsun Research and Training Hospital; 🇹🇷 Samsun, Turkey

Karadeniz Teknik University Medical Faculty; 🇹🇷 Trabzon, Turkey