Clinical trial NCT04740515: Influence of a PPMTM on Adherence and Clinical Outcomes Among Preterm Infants With Iron Supplementation
Official title: Evaluation of the Influence of a Pharmacist-led Patient-Centered Medication Therapy Management on Adherence and Clinical Outcomes Among Preterm Infants With Iron Supplementation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Preterm Infants
Clinical Outcome
Pharmaceutical Care
Keywords: Pharmaceutical Care
Medication Adherence
Iron Supplementation
Lead sponsor: Shaoxing Maternity and Child Health Care Hospital
Sponsor class: OTHER
First posted: 2021-02-05
Enrollment: 236
Sex: ALL
Minimum age (years): 26
Maximum age (years): 32
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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

Primary outcomes:
measure: ferritin level
timeFrame: At discharge or 40 weeks corrected age (whichever occurs first), Correct gestational age of 3 months and 6 months
measure: hemoglobin level
timeFrame: At discharge or 40 weeks corrected age (whichever occurs first), Correct gestational age of 3 months and 6 months
measure: reticulocyte hemoglobin equivalent (Ret-He, pg)
timeFrame: At discharge or 40 weeks corrected age (whichever occurs first), Correct gestational age of 3 months and 6 months
measure: reticulocyte count (%)
timeFrame: At discharge or 40 weeks corrected age (whichever occurs first), Correct gestational age of 3 months and 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Shaoxing
country: China
facility: Shaoxing Maternity and Child Care hospital
state: Zhejiang
Study officials:
affiliation: Shaoxing Maternity and Child Health Care Hospital
name: Renjie Xu, PhD
role: PRINCIPAL_INVESTIGATOR
References: