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

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

Detailed Description
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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.

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

Conditions
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Other Preterm Infants

Intervention / Treatment
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* Other: Preterm infant formula per standard of care


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Maximum Age: 21 Days

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Preterm/low birth weight infants<br>Preterm infant formula per standard of care | Other: Preterm infant formula per standard of care<br>* Commercially available preterm infant formula<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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 |