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

NCT04740515 | Completed

• 1 other identifier: XRenjie
• Study Type: interventional
• Target: 236
• Locations: 1 country
• Sites: 1

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.

Conditions

Preterm Infants; Clinical Outcome; Pharmaceutical Care

Keywords

Pharmaceutical Care; Medication Adherence; Iron Supplementation

Outcome Measures

Primary Outcomes (4)

• 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

Study Arms (2)

Involvement of pharmacists in improving medication

EXPERIMENTAL

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

usual care only

NO INTERVENTION

Patients were provided with usual care.

Interventions

pharmacists involved PPMTM OTHER

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.

Involvement of pharmacists in improving medication

Eligibility Criteria

• Age: 26 Weeks - 32 Weeks
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Shaoxing Maternity and Child Health Care Hospital: lead

Study Sites (1)

Shaoxing Maternity and Child Care hospital

Shaoxing, Zhejiang, 312000, China

Location

MeSH Terms

Conditions

Medication Adherence

Condition Hierarchy (Ancestors)

Patient Compliance; Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior; Behavior

Study Officials

• Renjie Xu, PhD

  Shaoxing Maternity and Child Health Care Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Department of Clinical pharmacy

Study Record Dates

• First Submitted: February 1, 2021
• First Posted: February 5, 2021
• Study Start: February 15, 2022
• Primary Completion: February 21, 2022
• Study Completion: August 8, 2023
• Last Updated: October 13, 2023

Record last verified: 2023-10

Locations

CN (1)