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NCT Number: NCT04740515

Influence of a PPMTM 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.

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Key information

Conditions

Preterm Infants Behavior Clinical Outcome Health Behavior Medication Adherence Patient Acceptance of Health Care Patient Compliance Pharmaceutical Care Treatment Adherence and Compliance

Age range

26 week–32 week

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Shaoxing Maternity and Child Care hospital

Shaoxing, Zhejiang, 312000, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. ferritin level

    Time frame: 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

  2. hemoglobin level

    Time frame: 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

  3. reticulocyte hemoglobin equivalent (Ret-He, pg)

    Time frame: 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

  4. reticulocyte count (%)

    Time frame: 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%

Sponsors and collaborators

Lead sponsor

Shaoxing Maternity and Child Health Care Hospital

Other

Registry information

Official study 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

Important dates

Study start
2022
Primary completion
2022
Study completion
2023
First posted
Feb 5, 2021
Registry last updated
Oct 13, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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