Clinical Outcome, Pharmaceutical Care, Preterm Infants
Conditions
Keywords
Pharmaceutical Care, Medication Adherence, Iron Supplementation
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.
Interventions
OTHERpharmacists involved PPMTM
This was an open labelled randomised study. Preterm Infants With iron supplementation were recruited and arbitrarily divided into the intervention group (usual care plus PPMTM) and the non-intervention group (usual care only). Those enrolled in the research were scheduled for follow-up for eight consecutive visits. Improvements in lab results and direct costs were compared longitudinally (pre and post analysis) between the groups.
Sponsors
Shaoxing Maternity and Child Health Care Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
26 Weeks to 32 Weeks
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| ferritin level | 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 | 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 |
| reticulocyte hemoglobin equivalent (Ret-He, pg) | 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 (%) | 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% |
Countries
China
Outcome results
None listed