Stopped: Study was conducted to fulfill a post marketing commitment (PMC). FDA acknowledged closure of PMC.
The purpose of this study is to determine if laronidase is present in the breast milk of post-partum women receiving Aldurazyme® (laronidase) and the effects of Aldurazyme (laronidase) on the growth, development, and immunologic response of their breastfed infants.
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
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.
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
Number of Lactating Women With Serum IgG Antibodies to Laronidase
Timeframe: Up to 18 months
Amount of IgG Antibody Titers to Laronidase in Lactating Women
Timeframe: Baseline and Week 12
Number of Women Who Breastfed
Timeframe: Up to 18 months
Number of Women Who Were Successful at Breastfeeding
Timeframe: Up to 18 months
Number of Women Whose Breast Milk Contains Laronidase
Timeframe: Up to 18 months
Amount of Laronidase in the Breast Milk of Lactating Mothers With Mucopolysaccharidosis I (MPS I) Disease
Timeframe: Up to 18 months
Number of Women With Abnormal Urine Glycosaminoglycans (uGAG) Levels
Timeframe: Up to 18 months
Amount of uGAG in the Urine of Women
Timeframe: Baseline and Week 12
Number of Participants With Medical History of the Mother: Pre-Existing Conditions
Timeframe: Baseline
Physical Examination Findings of the Mother
Timeframe: Up to 18 months
Temperature of the Mother
Timeframe: Baseline and Week 12
Heart Rate of the Mother
Timeframe: Baseline and Week 12
Respiratory Rate of the Mother
Timeframe: Baseline and Week 12
Blood Pressure of the Mother
Timeframe: Baseline and Week 12
Weight of the Mother
Timeframe: Baseline and Week 12
Height of the Mother
Timeframe: Baseline
Number of Infants With Abnormal uGAG Levels
Timeframe: Up to 72 weeks
Amount of uGAG in the Urine of Infants
Timeframe: Baseline, Week 12, Week 24, Week 36, Week 48, Week 60, and Week 72
Number of Participants With Medical History of the Infant:Pre-Existing Conditions
Timeframe: Baseline
Number of Infants With Abnormal Physical Finding
Timeframe: Baseline, Week 12, Week 24, Week 36, Week 48, and Week 72
Heart Rate of the Infant
Timeframe: Baseline, Week 12, Week 24, Week 36, Week 48, and Week 72
Respiratory Rate of the Infant
Timeframe: Baseline, Week 12, Week 24, Week 36, Week 48, and Week 72
Blood Pressure of the Infant
Timeframe: Baseline, Week 12, Week 24, Week 36, Week 48, and Week 72
Weight of the Infant
Timeframe: Baseline, Week 12, Week 24, Week 36, Week 48, and Week 72
Height of the Infant
Timeframe: Baseline, Week 12, Week 24, Week 36, Week 48, and Week 72
Temperature of the Infant
Timeframe: Baseline, Week 12, Week 24, Week 36, Week 48, and Week 72
Head Circumference of the Infant
Timeframe: Baseline, Week 12, Week 24, Week 36, Week 48, and Week 72
Number of Participants With Normal Overall Assessment Measured Using Denver II Developmental Screening Scores
Timeframe: Week 12, Week 24, Week 36, Week 48, and Week 72
Number of Infants With IgM and IgG Antibodies to Laronidase Present at Any Time Point
Timeframe: Baseline, Week 12, Week 24, Week 36, and Week 72
Time to Development of IgM and IgG Antibodies to Laronidase
Timeframe: up to Week 72
Amount of IgG and IgM Antibody Titers to Laronidase
Timeframe: Baseline, Week 12, Week 24, Week 36, and Week 72