Effects of Infant Formula on the Growth and Tolerance in Preterm/Low Birth Weight Infants (NCT02073071) | Clinical Trial Compass
CompletedNot Applicable
Effects of Infant Formula on the Growth and Tolerance in Preterm/Low Birth Weight Infants
China139 participantsStarted 2014-05
Plain-language summary
This is a two stage open-label, single-arm, multicenter and observational study.
Who can participate
Age range21 Days
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 disease…
What they're measuring
1
Weight
Timeframe: Change from first feeding to discharge (up to ~8 weeks)