Back to resultsInfluence of a PPMTM on Adherence and Clinical Outcomes Among Preterm Infants With Iron Supplementation
Primary Purpose
Preterm Infants, Clinical Outcome, Pharmaceutical Care
Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
pharmacists involved PPMTM
Sponsored by
About this trial
This is an interventional supportive care trial for Preterm Infants focused on measuring Pharmaceutical Care, Medication Adherence, Iron Supplementation
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
Sites / Locations
- Shaoxing Maternity and Child Care hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Involvement of pharmacists in improving medication
usual care only
Arm Description
Pharmacists involved care group. Tools used to improve medication adherence, (1)Patient medication guide (2)tailored Short Messaging Service (SMS) (3)Pharmaceutical follow-up
Patients were provided with usual care.
Outcomes
Primary Outcome Measures
ferritin level
Iron insufficiency will be determined by ferritin level less than 70 ng/mL
hemoglobin level
Iron insufficiency will be determined by hemoglobin level less than 8 g/dL
reticulocyte hemoglobin equivalent (Ret-He, pg)
Iron insufficiency will be determined by Ret-He less than 27.2 pg
reticulocyte count (%)
Iron insufficiency will be determined by reticulocyte count less than 2%
Secondary Outcome Measures
Full Information
NCT ID
NCT04740515
First Posted
February 1, 2021
Last Updated
October 11, 2023
Sponsor
Shaoxing Maternity and Child Health Care Hospital
1. Study Identification
Unique Protocol Identification Number
NCT04740515
Brief Title
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
2. Study Status
Record Verification Date
October 2023
Overall Recruitment Status
Completed
Study Start Date
February 15, 2022 (Actual)
Primary Completion Date
February 21, 2022 (Actual)
Study Completion Date
August 8, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Shaoxing Maternity and Child Health Care Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Preterm Infants, Clinical Outcome, Pharmaceutical Care
Keywords
Pharmaceutical Care, Medication Adherence, Iron Supplementation
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
236 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Involvement of pharmacists in improving medication
Arm Type
Experimental
Arm Description
Pharmacists involved care group. Tools used to improve medication adherence, (1)Patient medication guide (2)tailored Short Messaging Service (SMS) (3)Pharmaceutical follow-up
Arm Title
usual care only
Arm Type
No Intervention
Arm Description
Patients were provided with usual care.
Intervention Type
Other
Intervention Name(s)
pharmacists involved PPMTM
Intervention Description
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.
Primary Outcome Measure Information:
Title
ferritin level
Description
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
Title
hemoglobin level
Description
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
Title
reticulocyte hemoglobin equivalent (Ret-He, pg)
Description
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
Title
reticulocyte count (%)
Description
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
26 Weeks
Maximum Age & Unit of Time
32 Weeks
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Renjie Xu, PhD
Organizational Affiliation
Shaoxing Maternity and Child Health Care Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Shaoxing Maternity and Child Care hospital
City
Shaoxing
State/Province
Zhejiang
ZIP/Postal Code
312000
Country
China
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Influence of a PPMTM on Adherence and Clinical Outcomes Among Preterm Infants With Iron Supplementation
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