Preterm InfantsNCT04740515
Influence of a PPMTM on Adherence and Clinical Outcomes Among Preterm Infants With Iron Supplementation
A study testing pharmacists involved PPMTM in people with Preterm Infants and Clinical Outcome, run by Shaoxing Maternity and Child Health Care Hospital at 1 site in China.
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. Read more about this study
- Who is it for?
- Ages 26 to 32 weeks
- Conditions the study is for
- Preterm Infants, Clinical Outcome, Pharmaceutical Care
- What is being tested?
- pharmacists involved PPMTM
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 236 participants
- Where
- 1 siteChina
- Study dates
- 15 Feb 2022to 8 Aug 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 26 to 32 weeks
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
China1 site
Shaoxing Maternity and Child Care hospital
Shaoxing, Zhejiang, 312000
About this study
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
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.
Read the 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.
- Conditions
- Preterm Infants, Clinical Outcome, Pharmaceutical Care
- Being tested
- pharmacists involved PPMTM
- Keywords
- Pharmaceutical Care, Medication Adherence, Iron Supplementation
- Medical subject headings
- Medication Adherence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
pharmacists involved PPMTMOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Other: pharmacists involved PPMTM |
| usual care only | No intervention | Patients were provided with usual care. |
What is being measured
The primary outcome is the main question the study is designed to answer.
ferritin level
Iron insufficiency will be determined by ferritin level less than 70 ng/mL
Measured: 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
Measured: 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
Measured: 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%
Measured: At discharge or 40 weeks corrected age (whichever occurs first), Correct gestational age of 3 months and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2021
- Study start15 Feb 2022
- Primary completion21 Feb 2022
- Study completion8 Aug 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Preterm InfantsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 236 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shaoxing Maternity and Child Health Care Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xu Renjie, Shaoxing Maternity and Child Health Care Hospital
- Investigators
- Renjie Xu, PhD, Principal investigator, Shaoxing Maternity and Child Health Care Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04740515
- Sponsor's protocol ID
- XRenjie
- Status last verified
- Oct 2023
- First submitted
- 1 Feb 2021
- Last updated
- 13 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 13 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04740515
- Acronym / sponsor ID
- XRenjie
- Conditions
- Preterm Infants, Clinical Outcome, Pharmaceutical Care
- Keywords
- Pharmaceutical Care, Medication Adherence, Iron Supplementation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 236 participants (actual)
- Lead sponsor
- Shaoxing Maternity and Child Health Care HospitalUniversity, hospital or other
- Study start
- 15 Feb 2022 (actual)
- Primary completion
- 21 Feb 2022 (actual)
- Study completion
- 8 Aug 2023 (actual)
- First posted
- 5 Feb 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Involvement of pharmacists in improving medication | Experimental | Other: pharmacists involved PPMTMPharmacists involved care group. Tools used to improve medication adherence, (1)Patient medication guide (2)tailored Short Messaging Service (SMS) (3)Pharmaceutical follow-up |
| usual care only | No intervention | –Patients were provided with usual care. |
Who may qualify
- Ages
- 26 to 32 weeks
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (1 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| pharmacists involved PPMTMThis 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. | Other | Involvement of pharmacists in improving medication |
Primary outcome
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
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
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
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%
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Oct 2023.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Renjie Xu, PhD principal investigator
Shaoxing Maternity and Child Health Care Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing pharmacists involved PPMTM in people with Preterm Infants and Clinical Outcome, run by Shaoxing Maternity and Child Health Care Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
ferritin level (time frame: At discharge or 40 weeks corrected age (whichever occurs first), Correct gestational age of 3 months and 6 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Oct 2023.