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

NCT02073071 | Completed

• 1 other identifier: DA05
• Study Type: observational
• Target: 139
• Locations: 1 country
• Sites: 10

Brief Summary

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

Conditions

Other Preterm Infants

Outcome Measures

Primary Outcomes (1)

• Weight

  Change from first feeding to discharge (up to ~8 weeks)

Secondary Outcomes (5)

• 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

  From first feeding to discharge (up to ~8 weeks)

• Catch Up Growth

  From discharge to 9 months corrected age

Study Arms (1)

Preterm/low birth weight infants

Preterm infant formula per standard of care

Other: Preterm infant formula per standard of care

Interventions

Preterm infant formula per standard of care OTHER

Commercially available preterm infant formula

Preterm/low birth weight infants

Eligibility Criteria

• Age: Up to 21 Days
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Probability Sample

Study Population

Hospital based preterm infants

You may qualify if:

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

You may not qualify if:

• 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.
• 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

Sponsors & Collaborators

• Abbott Nutrition: lead

Study Sites (10)

Guangdong General Hospital

Guangzhou, Guangdong, China

Location

The First Affiliated Hospital, Sun Yat-sen University

Guangzhou, Guangdong, China

Location

Hunan Children's Hospital

Changsha, Hunan, China

Location

The Second Xiangya Hospital of Central South University

Changsha, Hunan, China

Location

Women's Hospital School Of Medicine Zhejiang University

Hangzhou, Zhejiang, China

Location

Peking University First Hospital

Beijing, China

Location

Children's hospital of Chongqing Medical University

Chongqing, China

Location

Children's Hospital of Shanghai

Shanghai, China

Location

Shanghai Children's Medical Center Affiliated to Shanghai Jiao Tong University School of Medicine

Shanghai, China

Location

Xin Hua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine

Shanghai, China

Location

Study Officials

• Xianfeng Zhao, MD, PhD

  Abbott Nutrition China

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 19, 2014
• First Posted: February 27, 2014
• Study Start: May 1, 2014
• Primary Completion: September 1, 2015
• Study Completion: November 1, 2015
• Last Updated: November 30, 2015

Record last verified: 2015-11

Locations

CN (10)