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

Other Preterm Infants Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02073071
• Other study ID #: DA05
• Status: Completed
• Phase: N/A
• First received: February 19, 2014
• Last updated: November 25, 2015
• Start date: May 2014
• Est. completion date: November 2015

Study information

• Verified date: November 2015
• Source: Abbott Nutrition
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Ethics Committee
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 139
• Est. completion date: November 2015
• Est. primary completion date: September 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 21 Days

Eligibility

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 Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Birth Weight
• Other Preterm Infants
• Premature Birth

Intervention

Other:
• Preterm infant formula per standard of care
Commercially available preterm infant formula

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Abbott Nutrition

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Weight		Change from first feeding to discharge (up to ~8 weeks)	No
Secondary	Length		Change from first feeding to discharge (up to ~8 weeks)	No
Secondary	Head Circumference		Change from first feeding to discharge (up to ~8 weeks)	No
Secondary	Hospitalization Length of Stay		Time from Birth to discharge (up to ~8 weeks)	No
Secondary	Gastrointestinal Tolerance	vomiting, abdominal distension, gastric residuals, stool abnormalities, necrotizing enterocolitis	From first feeding to discharge (up to ~8 weeks)	No
Secondary	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	No