Influence of a PPMTM on Adherence and Clinical Outcomes Among Preterm Infants With Iron Supplementation

Shaoxing Maternity and Child Health Care Hospital236 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

NONE

Enrollment

236

Conditions

Preterm Infants Clinical Outcome Pharmaceutical Care

Interventions

pharmacists involved PPMTMOTHER

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.

Eligibility

Sex: ALLMin age: 26 WeeksMax age: 32 Weeks

Medical Language ↔ Plain English

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

Locations (1)

Shaoxing Maternity and Child Care hospital

Shaoxing, Zhejiang, China

Outcomes

Primary Outcomes

ferritin level

Iron insufficiency will be determined by ferritin level less than 70 ng/mL

Time frame: At discharge or 40 weeks corrected age (whichever occurs first), Correct gestational age of 3 months and 6 months

hemoglobin level

Iron insufficiency will be determined by hemoglobin level less than 8 g/dL

Time frame: At discharge or 40 weeks corrected age (whichever occurs first), Correct gestational age of 3 months and 6 months

reticulocyte hemoglobin equivalent (Ret-He, pg)

Iron insufficiency will be determined by Ret-He less than 27.2 pg

Time frame: At discharge or 40 weeks corrected age (whichever occurs first), Correct gestational age of 3 months and 6 months

reticulocyte count (%)

Iron insufficiency will be determined by reticulocyte count less than 2%

Time frame: At discharge or 40 weeks corrected age (whichever occurs first), Correct gestational age of 3 months and 6 months

Data from ClinicalTrials.gov

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