Clinical trial NCT03597113: Evaluation of Infants Fed an Extensively Hydrolyzed Hypo Allergenic Infant Formula
Official title: Growth and Compliance of Infants Fed an Extensively Hydrolyzed Hypo Allergenic Infant Formula
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Gastrointestinal Tolerance
Lead sponsor: Abbott Nutrition
Sponsor class: INDUSTRY
First posted: 2018-07-24
Enrollment: 320
Sex: ALL
Minimum age (years): 0
Maximum age (years): 180
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subjects will be enrolled from outpatient clinics and physician offices.

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.


Eligibility criteria: 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

Primary outcomes:
measure: Weight
timeFrame: Baseline to Study Day 30
Secondary outcomes:
measure: Formula Intake
timeFrame: Baseline to Study Day 30
Other outcomes:
Locations:
city: Adana
country: Turkey
facility: Adana City Hospital
city: Afyon
country: Turkey
facility: Afyon Kocatepe University Medical Faculty
city: Ankara
country: Turkey
facility: Ankara Dr. Sami Ulus Women and Child Disesase Research and Training Hospital B
city: Ankara
country: Turkey
facility: Hacettepe Üniversitesi University Medical Faculty A
city: Ankara
country: Turkey
facility: Hacettepe Üniversitesi University Medical Faculty B
city: Ankara
country: Turkey
facility: Ankara Dışkapı Child Disease Hospital A
city: Ankara
country: Turkey
facility: Ankara Dışkapı Child Disease Hospital B
city: Ankara
country: Turkey
facility: Ankara Research and Training Hospital
city: Ankara
country: Turkey
facility: Ankara Yıldırım Beyazıt University Yenimahalle Research and Training Hospital
city: Ankara
country: Turkey
facility: Gazi Üniversitesi University Medical Faculty
city: Ankara
country: Turkey
facility: Ankara University Medical Faculty
city: Antalya
country: Turkey
facility: Akdeniz University Medical Faculty A
city: Antalya
country: Turkey
facility: Akdeniz University Medical Faculty B
city: Balıkesir
country: Turkey
facility: Balıkesir University Research and Training Hospital
city: Bursa
country: Turkey
facility: TC Sağlık Bilimleri University Bursa Yuksek Intisas Research and Training Hospital
city: Denizli
country: Turkey
facility: Pamukkale University Medical Faculty A
city: Denizli
country: Turkey
facility: Pamukkale University Medical Faculty B
city: Elazığ
country: Turkey
facility: Fırat Üniversitesi University Medical Faculty
city: Erzurum
country: Turkey
facility: Erzurum Research and Training Hospital
city: Gaziantep
country: Turkey
facility: Gaziantep University Medical Faculty
city: Hatay
country: Turkey
facility: Hatay State Hospital
city: İstanbul
country: Turkey
facility: İstanbul University İstanbul Medical School A
city: İstanbul
country: Turkey
facility: İstanbul University Cerrahpaşa Medical School
city: İstanbul
country: Turkey
facility: İstanbul Bakırköy Dr. Sadi Konuk Research and Training Hospital
city: Istanbul
country: Turkey
facility: Istanbul Esenler Women and Children Diseases Hospital
city: İstanbul
country: Turkey
facility: İstanbul Atakent Acıbadem Hospital
city: İstanbul
country: Turkey
facility: İstanbul Kanuni Sultan Süleyman Research and Training Hospital A
city: İstanbul
country: Turkey
facility: İstanbul Sisli Hamidiye Etfal Research and Training Hospital C
city: İstanbul
country: Turkey
facility: İstanbul Şişli Hamidiye Etfal Research and Training Hospital A
city: İstanbul
country: Turkey
facility: İstanbul Şişli Hamidiye Etfal Research and Training Hospital B
city: İstanbul
country: Turkey
facility: İstanbul Okmeydanı Research and Training Hospital
city: İstanbul
country: Turkey
facility: İstanbul Maslak Acıbadem Hospital
city: İstanbul
country: Turkey
facility: İstanbul Altunizade Acıbadem Hospital
city: İstanbul
country: Turkey
facility: İstanbul Göztepe Research and Training Hospital
city: İstanbul
country: Turkey
facility: İstanbul Ümraniye Research and Training Hospital A
city: İstanbul
country: Turkey
facility: İstanbul Ümraniye Research and Training Hospital B
city: Kocaeli
country: Turkey
facility: Kocaeli Üniversitesi University Medical Faculty
city: Konya
country: Turkey
facility: Konya Necmettin Erbakan University Medical Faculty
city: Konya
country: Turkey
facility: Konya Başkent University Hospital
city: Konya
country: Turkey
facility: Konya Selçuk University Medical Faculty
city: Kırıkkale
country: Turkey
facility: Kırıkkale University Medical Faculty
city: Malatya
country: Turkey
facility: İnönü Üniversitesi University Medical Faculty
city: Samsun
country: Turkey
facility: Samsun Research and Training Hospital
city: Trabzon
country: Turkey
facility: Karadeniz Teknik University Medical Faculty
city: Trabzon
country: Turkey
facility: Trabzon Kanuni Research and Training Hospital
city: Zonguldak
country: Turkey
facility: Zonguldak Bülent Ecevit University Research and Training Hospital
Study officials:
affiliation: Abbott Turkey
name: Aysugul Alptekin, MD
role: STUDY_CHAIR
References: