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 range
21 Days
Sex
ALL
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…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Weight
Timeframe: Change from first feeding to discharge (up to ~8 weeks)