Clinical trial NCT02073071: Effects of Infant Formula on the Growth and Tolerance in Preterm/Low Birth Weight Infants
Official title: Effects of Infant Formula on the Growth and Tolerance in Preterm/Low Birth Weight Infants
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Other Preterm Infants
Lead sponsor: Abbott Nutrition
Sponsor class: INDUSTRY
First posted: 2014-02-27
Enrollment: 139
Sex: ALL
Maximum age (years): 21
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Hospital based preterm infants

Brief summary: This is a two stage open-label, single-arm, multicenter and observational study.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria for Stage 1:

* Less than or equal to 34 weeks gestational age at birth, and birth weight ≥ 1000g to \< 1800g;
* 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;

Inclusion Criteria for Stage 2:

* Infants with birth weight \< or = 1500g, subjects whose parents/guardians and investigators have selected NeoSure for continued feeding after hospital discharge.

Exclusion Criteria for Stage 1:

* Serious congenital chromosomal or metabolic abnormalities that may affect growth and development;
* 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.

Exclusion Criteria for Stage 2:

* 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

Primary outcomes:
measure: Weight
timeFrame: Change from first feeding to discharge (up to ~8 weeks)
Secondary outcomes:
measure: Length
timeFrame: Change from first feeding to discharge (up to ~8 weeks)
measure: Head Circumference
timeFrame: Change from first feeding to discharge (up to ~8 weeks)
measure: Hospitalization Length of Stay
timeFrame: Time from Birth to discharge (up to ~8 weeks)
measure: Gastrointestinal Tolerance
timeFrame: From first feeding to discharge (up to ~8 weeks)
measure: Catch Up Growth
timeFrame: From discharge to 9 months corrected age
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Guangdong General Hospital
state: Guangdong
city: Guangzhou
country: China
facility: The First Affiliated Hospital, Sun Yat-sen University
state: Guangdong
city: Changsha
country: China
facility: Hunan Children's Hospital
state: Hunan
city: Changsha
country: China
facility: The Second Xiangya Hospital of Central South University
state: Hunan
city: Hangzhou
country: China
facility: Women's Hospital School Of Medicine Zhejiang University
state: Zhejiang
city: Beijing
country: China
facility: Peking University First Hospital
city: Chongqing
country: China
facility: Children's hospital of Chongqing Medical University
city: Shanghai
country: China
facility: Children's Hospital of Shanghai
city: Shanghai
country: China
facility: Shanghai Children's Medical Center Affiliated to Shanghai Jiao Tong University School of Medicine
city: Shanghai
country: China
facility: Xin Hua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
Study officials:
affiliation: Abbott Nutrition China
name: Xianfeng Zhao, MD, PhD
role: STUDY_CHAIR
References: