Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Preterm/low birth weight infants | Preterm infant formula per standard of care |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Preterm infant formula per standard of care | Other | Commercially available preterm infant formula |
|
| Measure | Description | Time Frame |
|---|---|---|
| Weight | Change from first feeding to discharge (up to ~8 weeks) |
| Measure | Description | Time Frame |
|---|---|---|
| Length | Change from first feeding to discharge (up to ~8 weeks) | |
| Head Circumference | Change from first feeding to discharge (up to ~8 weeks) | |
| Hospitalization Length of Stay |
Not provided
Inclusion Criteria for Stage 1:
Inclusion Criteria for Stage 2:
Exclusion Criteria for Stage 1:
Exclusion Criteria for Stage 2:
Not provided
Not provided
Not provided
Hospital based preterm infants
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Xianfeng Zhao, MD, PhD | Abbott Nutrition China | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Guangdong General Hospital | Guangzhou | Guangdong | China | |||
| The First Affiliated Hospital, Sun Yat-sen University |
Not provided
Not provided
Not provided
Not provided
| Time from Birth to discharge (up to ~8 weeks) |
| Gastrointestinal Tolerance | vomiting, abdominal distension, gastric residuals, stool abnormalities, necrotizing enterocolitis | 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. | From discharge to 9 months corrected age |
| 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 |