Extremely Low Birth WeightNCT05146752
The Effect of Schumann Resonance on Preterm Newborns
A study testing extremely low frequency electromagnetic fields and routine care in people with Extremely Low Birth Weight, run by Chung Shan Medical University at 1 site in Taiwan.
Trial summary
Body weight gain is crucial for preterm newborns, especially those with a low birth weight. Owing to their noninvasive, noncontact, and non-pharmaceutical properties, extremely low frequency electromagnetic fields (ELF-EMFs) are a promising medium of alternative and complementary therapy. Read more about this study
- Who is it for?
- Ages 26 to 42 weeksHealthy volunteers can take part
- Conditions the study is for
- Extremely Low Birth Weight
- What is being tested?
- extremely low frequency electromagnetic fields and routine care
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 61 participants
- Where
- 1 siteTaiwan
- Study dates
- 8 Jun 2019to 5 Jun 2021
- 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 42 weeks
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- gestational age (GA) between 32 and 35 weeks
- Neonatal Therapeutic Intervention Scoring System (NTISS) score <9
Who cannot join
- (1) a diagnosis of congenital anomaly, intrauterine growth retardation, cerebral palsy, or hydrocephalus; (2) an NTISS score>9
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Application of Schumann Resonance on Premature Infant
Body weight gain is crucial for preterm newborns, especially those with a low birth weight. Owing to their noninvasive, noncontact, and non-pharmaceutical properties, extremely low frequency electromagnetic fields (ELF-EMFs) are a promising medium of alternative and complementary therapy.
Read the detailed description
Sixty-one preterm newborns of 32-35 weeks' gestational age were recruited from the neonatal intensive care unit of the Chung Shan Medical University Hospital and randomly assigned to one of two groups: the experimental group (n = 31) or the control group (n = 30). Both groups received the same medical care, but the experimental group was exposed to ELF-EMFs until discharge.
- Conditions
- Extremely Low Birth Weight
- Being tested
- extremely low frequency electromagnetic fields, routine care
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
extremely low frequency electromagnetic fieldsDevice
extremely low frequency electromagnetic fields
routine careOther
routine care
| Study group | Role | What they receive |
|---|---|---|
| Extremely low frequency electromagnetic fields | Experimental | After parental permission for participation was obtained, the preterm newborns were enrolled and divided into the experimental group, which received ELF-EMF therapy after a pretest in addition to regular medical care, and the control group, which received regular medical care only, using a random number table. Receives: Device: extremely low frequency electromagnetic fields |
| control group | Other | routine care Receives: Other: routine care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline body weight gain at 4 weeks
Although the preterm newborns' body weight was recorded daily, the differences in body weight gain between the two groups were compared every week.The body weights of the preterm newborns were recorded using the same weighing scale at the same time every day.
Measured: Baseline, week1, week2, week3, week4.
Secondary outcomes (1)
Change from Baseline sleep quality at 4 weeks
The preterm newborns' sleep quality was recorded daily, the differences in sleep quality between the two groups were compared every week. The preterm' sleep quality was recorded by the sleep tracking devices of Fitbit Alta HR. The correlation coefficient between Alta HR and PSG was 0.85~0.87.
Measured: Baseline, week1, week2, week3, week4.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Dec 2021
- Study start8 Jun 2019
- Primary completion1 Feb 2021
- Study completion5 Jun 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Extremely Low Birth WeightStudies 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
- 61 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chung Shan Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hsiao-Ling Chuang, Chung Shan Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05146752
- Sponsor's protocol ID
- CS19049
- Status last verified
- Dec 2021
- First submitted
- 9 Nov 2021
- Last updated
- 7 Dec 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Application of Schumann Resonance on Premature Infant
- ClinicalTrials.gov ID
- NCT05146752
- Acronym / sponsor ID
- CS19049
- Conditions
- Extremely Low Birth Weight
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 61 participants (actual)
- Lead sponsor
- Chung Shan Medical UniversityUniversity, hospital or other
- Study start
- 8 Jun 2019 (actual)
- Primary completion
- 1 Feb 2021 (actual)
- Study completion
- 5 Jun 2021 (actual)
- First posted
- 7 Dec 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.
Body weight gain is crucial for preterm newborns, especially those with a low birth weight. Owing to their noninvasive, noncontact, and non-pharmaceutical properties, extremely low frequency electromagnetic fields (ELF-EMFs) are a promising medium of alternative and complementary therapy.
Detailed description
Sixty-one preterm newborns of 32-35 weeks' gestational age were recruited from the neonatal intensive care unit of the Chung Shan Medical University Hospital and randomly assigned to one of two groups: the experimental group (n = 31) or the control group (n = 30). Both groups received the same medical care, but the experimental group was exposed to ELF-EMFs until discharge.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Extremely low frequency electromagnetic fields | Experimental | Device: extremely low frequency electromagnetic fieldsAfter parental permission for participation was obtained, the preterm newborns were enrolled and divided into the experimental group, which received ELF-EMF therapy after a pretest in addition to regular medical care, and the control group, which received regular medical care only, using a random number table. |
| control group | Other | Other: routine careroutine care |
Who may qualify
- Ages
- 26 to 42 weeks
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- gestational age (GA) between 32 and 35 weeks
- Neonatal Therapeutic Intervention Scoring System (NTISS) score <9
Key exclusion criteria (1 listed)
- (1) a diagnosis of congenital anomaly, intrauterine growth retardation, cerebral palsy, or hydrocephalus; (2) an NTISS score>9
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 |
|---|---|---|
| extremely low frequency electromagnetic fieldsextremely low frequency electromagnetic fields | Device | Extremely low frequency electromagnetic fields |
| routine careroutine care | Other | control group |
Primary outcome
Change from Baseline body weight gain at 4 weeks
Time frame: Baseline, week1, week2, week3, week4.
Although the preterm newborns' body weight was recorded daily, the differences in body weight gain between the two groups were compared every week.The body weights of the preterm newborns were recorded using the same weighing scale at the same time every day.
1 secondary outcome
Change from Baseline sleep quality at 4 weeks
Time frame: Baseline, week1, week2, week3, week4.
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 7 Dec 2021.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing extremely low frequency electromagnetic fields and routine care in people with Extremely Low Birth Weight, run by Chung Shan Medical University at 1 site in Taiwan.
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 7 Dec 2021. 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 Taiwan. 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?
Change from Baseline body weight gain at 4 weeks (time frame: Baseline, week1, week2, week3, week4.). 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 7 Dec 2021.