Evaluation of the Influence of a Pharmacist-led Patient-Centered Medication Therapy Management on Adherence and Clinical Outcomes Among Preterm Infants With Iron Supplementation
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Preterm Infants
- Sponsor
- Shaoxing Maternity and Child Health Care Hospital
- Enrollment
- 236
- Locations
- 1
- Primary Endpoint
- reticulocyte hemoglobin equivalent (Ret-He, pg)
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief Summary
This is a randomised trial on the efficacy of a Pharmacist-led Patient-Centered Medication Therapy Management on clinical outcomes among preterm infants born before 32 weeks gestation with iron supplementation. The purpose of this study is to evaluate clinical outcome in the PPMTM program compared with usual care in an integrated health care system.
Detailed Description
This is a randomised trial on the efficacy of a Pharmacist-led Patient-Centered Medication Therapy Management on clinical outcomes among preterm infants born before 32 weeks gestation with iron supplementation. As a result, the Committee on Nutrition of the American Academy of Pediatrics (AAP) recommends daily oral iron supplementation, of at least 2-4 mg/kg/day from 2 weeks of age, to prevent iron deficiency in extremely premature infants. The purpose of this study is to evaluate clinical outcome in the PPMTM program compared with usual care in an integrated health care system.
Investigators
Xu Renjie
Department of Clinical pharmacy
Shaoxing Maternity and Child Health Care Hospital
Eligibility Criteria
Inclusion Criteria
- •NICU inpatients between 26 and 32 weeks of gestation Infants older than two week of age and Iron dosing will be adjusted for weight at weekly intervals to maintain dosing at 4mg/kg/day.
- •Parental permission obtained prior to start of study
Exclusion Criteria
- •In extremis during consent window (as judged by primary attending provider) Known or suspected genetic disorder Small for gestational age (birth weight below the 10th percentile for gestational age) Unable to return for follow-up evaluation at 6 months of age
Outcomes
Primary Outcomes
reticulocyte hemoglobin equivalent (Ret-He, pg)
Time Frame: At discharge or 40 weeks corrected age (whichever occurs first), Correct gestational age of 3 months and 6 months
Iron insufficiency will be determined by Ret-He less than 27.2 pg
reticulocyte count (%)
Time Frame: At discharge or 40 weeks corrected age (whichever occurs first), Correct gestational age of 3 months and 6 months
Iron insufficiency will be determined by reticulocyte count less than 2%
ferritin level
Time Frame: At discharge or 40 weeks corrected age (whichever occurs first), Correct gestational age of 3 months and 6 months
Iron insufficiency will be determined by ferritin level less than 70 ng/mL
hemoglobin level
Time Frame: At discharge or 40 weeks corrected age (whichever occurs first), Correct gestational age of 3 months and 6 months
Iron insufficiency will be determined by hemoglobin level less than 8 g/dL