Effects of Infant Formula on the Growth and Tolerance in Preterm/Low Birth Weight Infants
NCT ID: NCT02073071
Last Updated: 2015-11-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
139 participants
OBSERVATIONAL
2014-05-31
2015-11-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Preterm/low birth weight infants
Preterm infant formula per standard of care
Preterm infant formula per standard of care
Commercially available preterm infant formula
Interventions
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Preterm infant formula per standard of care
Commercially available preterm infant formula
Eligibility Criteria
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Inclusion Criteria
* Apgar score in 5 minutes after birth ≥ 7;
* Infant is 21 days or less of age at enrollment;
* Only singleton or twin births;
* Infants who can receive early enteral feeding stably (reaching 50% or higher of the required daily total calories) and whose parents/guardians and investigators have selected Similac Special Care (SSC) for feeding;
* Infant has been classified as appropriate for gestational age (AGA) or if classified as asymmetric small for gestational age (SGA) (Asymmetric SGA: Weight below the 10th percentile, but head circumference is greater than or equal to the 10th percentile) enrollment has been preapproved by sponsor;
* Infants with birth weight \< or = 1500g, subjects whose parents/guardians and investigators have selected NeoSure for continued feeding after hospital discharge.
Exclusion Criteria
* Congenital gastrointestinal malformations , including but not limited to congenital megacolon or gastric-intestinal perforation;
* Serious complications associated with preterm birth, including but not limited to necrotizing enterocolitis (NEC), septicemia or sepsis;
* Other serious disorders of cardiac/respiratory/endocrine/hematological/ gastrointestinal/other systems, or serious diseases requiring surgical intervention;
* Maternal incapacity: including maternal drug, cocaine or alcohol abuse during pregnancy or current;
* Infants who received any experimental treatment, participated in other clinical trials or received other study interventions unrelated to this study within 30 days prior to enrollment;
* Infants who have received or planned to receive breastfeeding or other infant formula (powder) other than SSC with calories intake ≥25% of the required daily total calories
* Intubation for ventilation at the time of enrollment.
* Infants who have received breastfeeding or other infant formula (powder) during hospitalization other than SSC with calories intake ≥25% of the required daily total calories
* Infants who have planned to receive breastfeeding or other infant formula (powder) other than NeoSure after discharge with calories intake ≥25% of the required daily total calories
21 Days
ALL
No
Sponsors
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Abbott Nutrition
INDUSTRY
Responsible Party
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Principal Investigators
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Xianfeng Zhao, MD, PhD
Role: STUDY_CHAIR
Abbott Nutrition China
Locations
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Guangdong General Hospital
Guangzhou, Guangdong, China
The First Affiliated Hospital, Sun Yat-sen University
Guangzhou, Guangdong, China
Hunan Children's Hospital
Changsha, Hunan, China
The Second Xiangya Hospital of Central South University
Changsha, Hunan, China
Women's Hospital School Of Medicine Zhejiang University
Hangzhou, Zhejiang, China
Peking University First Hospital
Beijing, , China
Children's hospital of Chongqing Medical University
Chongqing, , China
Children's Hospital of Shanghai
Shanghai, , China
Shanghai Children's Medical Center Affiliated to Shanghai Jiao Tong University School of Medicine
Shanghai, , China
Xin Hua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
Shanghai, , China
Countries
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Other Identifiers
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DA05
Identifier Type: -
Identifier Source: org_study_id