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

Not Applicable

Completed

• Conditions: Clinical Outcome; Pharmaceutical Care; Preterm Infants
• Interventions: Other: pharmacists involved PPMTM

• Registration Number: NCT04740515
• Lead Sponsor: Shaoxing Maternity and Child Health Care Hospital

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.

Study Timeline

• Study First Submitted: 2021-02-01
• Study First Submitted QC: 2021-02-01
• Study First Posted: 2021-02-05
• Study Start: 2022-02-15
• Primary Completion: 2022-02-21
• Study Completion: 2023-08-08
• Status Verified: 2023-10
• Last Update Submitted: 2023-10-11
• Last Update Posted: 2023-10-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 236

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Involvement of pharmacists in improving medication	pharmacists involved PPMTM	Pharmacists involved care group. Tools used to improve medication adherence, (1)Patient medication guide (2)tailored Short Messaging Service (SMS) (3)Pharmaceutical follow-up

Primary Outcome Measures

Name	Time	Method
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%
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

Trial Locations

Locations (1)

Shaoxing Maternity and Child Care hospital; 🇨🇳 Shaoxing, Zhejiang, China