Effects of Infant Formula on the Growth and Tolerance in Preterm/Low Birth Weight Infants
Data Collection
Collected from today forward - ProspectiveCohort
Tracking disease incidence in order to identify risk factors and understand disease progression over time.Summary
Study start date: May 1, 2014
Actual date on which the first participant was enrolled.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.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.139 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Cohort
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.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
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.Study Objectives
Primary Objectives
Secondary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 10 locations
The First Affiliated Hospital, Sun Yat-sen University
Guangzhou, ChinaHunan Children's Hospital
Changsha, ChinaThe Second Xiangya Hospital of Central South University
Changsha, China