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

Evaluation of the Influence of a Pharmacist-led Patient-Centered Medication Therapy Management on Adherence and Clinical Outcomes Among Preterm Infants With Iron Supplementation

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.

Study Overview

• Status: Recruiting
• Conditions: Preterm Infants; Pharmaceutical Care; Clinical Outcome
• Intervention / Treatment: Other: pharmacists involved PPMTM

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 Type: Interventional
• Enrollment (Anticipated): 500
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Renjie Xu, PhD; Phone Number: +86-575-85081798; Email: [email protected]

Study Locations

• China
  • Zhejiang
    • Shaoxing, Zhejiang, China, 312000
      • Recruiting
      • Shaoxing Maternity and Child Care hospital
      • Contact: Renjie Xu, Ph.D

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 5 months to 7 months (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Involvement of pharmacists in improving medication; Pharmacists involved care group. Tools used to improve medication adherence, (1)Patient medication guide (2)tailored Short Messaging Service (SMS) (3)Pharmaceutical follow-up	Other: pharmacists 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.
No Intervention: usual care only; Patients were provided with usual care.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
ferritin level	Iron insufficiency will be determined by ferritin level less than 70 ng/mL	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	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	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%	At discharge or 40 weeks corrected age (whichever occurs first), Correct gestational age of 3 months and 6 months

Collaborators and Investigators

• Sponsor: Shaoxing Maternity and Child Health Care Hospital
• Investigators: Principal Investigator: Renjie Xu, PhD, Shaoxing Maternity and Child Health Care Hospital

Study record dates

Study Major Dates

• Study Start (Anticipated): February 15, 2022
• Primary Completion (Anticipated): February 9, 2024
• Study Completion (Anticipated): February 8, 2025

Study Registration Dates

• First Submitted: February 1, 2021
• First Submitted That Met QC Criteria: February 1, 2021
• First Posted (Actual): February 5, 2021

Study Record Updates

• Last Update Posted (Actual): January 20, 2022
• Last Update Submitted That Met QC Criteria: January 15, 2022
• Last Verified: January 1, 2022

More Information

Terms related to this study

• Keywords: Medication Adherence; Pharmaceutical Care; Iron Supplementation
• Additional Relevant MeSH Terms: Pregnancy Complications; Obstetric Labor Complications; Obstetric Labor, Premature; Premature Birth
• Other Study ID Numbers: XRenjie

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No