Effects of Infant Formula on the Growth and Tolerance in Preterm/Low Birth Weight Infants

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

Study Overview

• Status: Completed
• Conditions: Other Preterm Infants
• Intervention / Treatment: Other: Preterm infant formula per standard of care

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.

• Study Type: Observational
• Enrollment (Actual): 139

Contacts and Locations

Study Locations

• China
  • Beijing, China
    • Peking University First Hospital
  • Chongqing, China
    • Children's Hospital of Chongqing Medical University
  • Shanghai, 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
  • Guangdong
    • Guangzhou, Guangdong, China
      • The First Affiliated Hospital, Sun Yat-sen University
    • Guangzhou, Guangdong, China
      • Guangdong General Hospital
  • Hunan
    • Changsha, Hunan, China
      • Hunan Children's Hospital
    • Changsha, Hunan, China
      • The Second Xiangya Hospital of Central South University
  • Zhejiang
    • Hangzhou, Zhejiang, China
      • Women's Hospital School of Medicine Zhejiang University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 3 weeks (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Hospital based preterm infants

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Preterm/low birth weight infants; Preterm infant formula per standard of care	Other: Preterm infant formula per standard of care; Commercially available preterm infant formula

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Weight	Change from first feeding to discharge (up to ~8 weeks)

Secondary Outcome Measures

Outcome Measure	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		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

Collaborators and Investigators

• Sponsor: Abbott Nutrition
• Investigators: Study Chair: Xianfeng Zhao, MD, PhD, Abbott Nutrition China

Study record dates

Study Major Dates

• Study Start: May 1, 2014
• Primary Completion (Actual): September 1, 2015
• Study Completion (Actual): November 1, 2015

Study Registration Dates

• First Submitted: February 19, 2014
• First Submitted That Met QC Criteria: February 26, 2014
• First Posted (Estimate): February 27, 2014

Study Record Updates

• Last Update Posted (Estimate): November 30, 2015
• Last Update Submitted That Met QC Criteria: November 25, 2015
• Last Verified: November 1, 2015

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Body Weight; Pregnancy Complications; Obstetric Labor Complications; Obstetric Labor, Premature; Premature Birth; Birth Weight
• Other Study ID Numbers: DA05

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No