This is a two stage open-label, single-arm, multicenter and observational study.
Stage 1: In hospital, preterm/low birth weight infants less than or equal to 34 weeks gestational age at birth, birth weight of ≥ 1000g to \<1800g and conditions meeting the enrollment criteria will be fed formula with or without parenteral nutrition until discharge. Stage 2: Post-discharge, all infants with birth weight \< or =1500g will be followed on formula per standard of care and accepted standard of care including feeding until the infant's weight \>or= 25th percentile of growth expectation based on corrected age (P25) or until infant reaches 9 months corrected age.
Study Type
OBSERVATIONAL
Enrollment
139
Commercially available preterm infant formula
Guangdong General Hospital
Guangzhou, Guangdong, China
The First Affiliated Hospital, Sun Yat-sen University
Guangzhou, Guangdong, China
Hunan Children's Hospital
Changsha, Hunan, China
Weight
Time frame: Change from first feeding to discharge (up to ~8 weeks)
Length
Time frame: Change from first feeding to discharge (up to ~8 weeks)
Head Circumference
Time frame: Change from first feeding to discharge (up to ~8 weeks)
Hospitalization Length of Stay
Time frame: Time from Birth to discharge (up to ~8 weeks)
Gastrointestinal Tolerance
vomiting, abdominal distension, gastric residuals, stool abnormalities, necrotizing enterocolitis
Time frame: From first feeding to discharge (up to ~8 weeks)
Catch Up Growth
From discharge to the time point that infant's weight \>or= 25th percentile of growth expectation based on corrected age (P25) or until infant reaches 9 months corrected age.
Time frame: From discharge to 9 months corrected age
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The Second Xiangya Hospital of Central South University
Changsha, Hunan, China
Women's Hospital School Of Medicine Zhejiang University
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Peking University First Hospital
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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