Prucalopride is a medicine used to treat constipation. The main aim of the study is to measure prucalopride concentrations in breast milk. Other aims are to check the growth and development of babies breastfed by their mothers who took prucalopride and to check if the babies had any side effects. During the study, participants will provide one set of milk samples over 24 hours using an electric breast pump. Breast milk samples will be collected at home and will be shipped to the laboratory. Also, participants will be asked questions during telephone interviews every 2 months in the first year of their baby's life. They will also be asked to complete growth and development questionnaires about their baby.
Study Type
OBSERVATIONAL
Enrollment
12
This is a non-interventional study.
University of California San Diego
La Jolla, California, United States
RECRUITINGDose- Normalized Area Under the Milk Concentration-time Curve of Prucalopride (AUC [milk, norm])
AUC \[milk, norm\] will be derived from a series of 7 timed, full expression breast milk samples collected from a single breast using an electric breast pump over a 24-hour period of milk collection after a dose following at least 5 consecutive daily doses. AUC \[milk, norm\] will be normalized to 2-milligrams (mg) daily maternal dose.
Time frame: Pre-dose, 1, 2, 4, 8, 12, and 24 hours post-dose on Day 1
Dose- Normalized Average Concentration of Prucalopride in Milk (C [ave, milk, norm])
C \[ave, milk, norm\] will be derived from a series of 7 timed, full expression breast milk samples collected from a single breast using an electric breast pump over a 24-hour period of milk collection after a dose following at least 5 consecutive daily doses. C \[ave, milk, norm\] will be normalized to 2-mg daily maternal dose.
Time frame: Pre-dose, 1, 2, 4, 8, 12, and 24 hours post-dose on Day 1
Time Interval Over Which the AUC [milk, norm] Measured (T)
Time interval over which the AUC \[milk, norm\] is measured (T) will be reported.
Time frame: Pre-dose, 1, 2, 4, 8, 12, and 24 hours post-dose on Day 1
Dose-normalized Daily Infant Dosage (DID [norm])
DID \[norm\] will be the estimated daily infant dose received by the infant through breastfeeding. DID \[norm\] will be normalized to 2-mg daily maternal dose.
Time frame: Pre-dose, 1, 2, 4, 8, 12, and 24 hours post-dose
Percentage of Maternal Dose or Relative Infant Dose (RID [%])
RID \[%\]will be calculated as DID \[norm\] divided by (2 mg/day/maternal body weight (kg)) then multiplied by 100.
Time frame: Up to 24 hours post-dose
Number of Infants With Adverse Events (AEs) Based on Maternal Report
Number of infants with AEs while being breastfed by a mother who is taking prucalopride will be obtained by maternal report (by phone).
Time frame: Up to 1 year of age
Change in Length During the First Year of Life in Infant's
Growth changes in length in centimeters every 2 months during the first year of life in infant's breastfed by mothers taking prucalopride will be obtained by maternal report (by phone), and medical records abstraction.
Time frame: At 6 and 12 months of age
Change in Weight During the First Year of Life in Infant's
Growth changes in weight in grams every 2 months during the first year of life in infant's breastfed by mothers taking prucalopride will be obtained by maternal report (by phone), and medical records abstraction.
Time frame: At 6 and 12 months of age
Change in Head Circumference During the First Year of Infant's Life
Change in head circumference at 6 and 12 months will be reported.
Time frame: At 6 and 12 months of age
Infant's Neurodevelopmental Performance Based on Ages and Stages Questionnaire-3 (ASQ-3)
Infant's neurodevelopmental progress at 12 months will be assessed by the ASQ-3 which will be completed by the mother. The ASQ-3 is a developmental screening instrument with 5 domains: (i) personal-social, (ii) gross motor, (iii) fine motor, (iv) problem solving, and (v) communication. All domains will be evaluated both continuously and categorically, with 3 categories: normal, borderline, abnormal. Abnormal scores of clinical concern are defined by test-based, standardized scoring criteria reported in the ASQ-3 User's Guide; these represent scores that are \<2.0 SDs below the mean for each category. Borderline scores are scores that fall between 2.0 and 1.5 SDs below the mean. Each domain has 6 questions, if the answer is Yes, score = 10, Sometimes = 5 and Not yet = 0. ASQ-3 average = average score of 5 aspects.
Time frame: Up to 1 year of age
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