Other Preterm Infants
Conditions
Brief summary
This is a two stage open-label, single-arm, multicenter and observational study.
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.
Interventions
OTHERPreterm infant formula per standard of care
Commercially available preterm infant formula
Sponsors
Abbott Nutrition
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
No minimum to 21 Days
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Weight | Change from first feeding to discharge (up to ~8 weeks) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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) | vomiting, abdominal distension, gastric residuals, stool abnormalities, necrotizing enterocolitis |
| Catch Up Growth | From discharge to 9 months corrected age | 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. |
Countries
China
Outcome results
None listed