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

Preterm Infants Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04740515
• Other study ID #: XRenjie
• Status: Completed
• Phase: N/A
• Start date: February 15, 2022
• Est. completion date: August 8, 2023

Study information

• Verified date: October 2023
• Source: Shaoxing Maternity and Child Health Care Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 236
• Est. completion date: August 8, 2023
• Est. primary completion date: February 21, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 26 Weeks to 32 Weeks

Eligibility

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

Related Conditions & MeSH terms

• Clinical Outcome
• Pharmaceutical Care
• Premature Birth
• Preterm Infants

Intervention

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.

Locations

Country	Name	City	State
China	Shaoxing Maternity and Child Care hospital	Shaoxing	Zhejiang

Sponsors (1)

Lead Sponsor	Collaborator
Shaoxing Maternity and Child Health Care Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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