Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 4:01 PM
Ignite Modification Date:
2025-12-24 @ 4:01 PM
NCT ID:
NCT04185766
Eligibility Criteria:
Inclusion Criteria
Mothers:
* Favourable for breastfeeding
* BMI between 19-24
Newborns:
* Late preterm (gestational age: 34-36 weeks)
* Term neonates (gestational age: 37-42 weeks), with body weight \<10th centile (SGA) or\> 90 ° centile according to Bertino's neonatal anthropometric evaluation
* Born from eutocic childbirth
* Rooming-in
* Body temperature between 36.5-37.5 ° C 2.
Exclusion criteria
Mothers:
* Lack of informed consent
* Diabetic mother
* Taking medicines during pregnancy (beta blockers, tolbutamide)
Newborns:
* Major congenital malformations
* Blood sugar \<47 mg / dl
* Body temperature \<36.5 ° C or\> 37.5 ° C
* NICU admissions
* Milk intake in formula
* Intravenous infusion of 10% glucose solution
* Metabolic and respiratory acidosis (pH: 7.28 - 7.38)
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
34 Weeks
Maximum Age:
42 Weeks
Study:
NCT04185766
Study Brief:
Protocol Section:
NCT04185766