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OpenTrials
Completed

NCT Number: NCT05146752

The Effect of Schumann Resonance on Preterm Newborns

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.

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Key information

Conditions

Extremely Low Birth Weight

Age range

26 week–42 week

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Chung Shan Medical University

Taichung, Taiwan

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • gestational age (GA) between 32 and 35 weeks
  • Neonatal Therapeutic Intervention Scoring System (NTISS) score <9

Exclusion criteria

  • (1) a diagnosis of congenital anomaly, intrauterine growth retardation, cerebral palsy, or hydrocephalus; (2) an NTISS score>9

Treatment and study plan

extremely low frequency electromagnetic fields

Device

extremely low frequency electromagnetic fields

Routine care

Other

routine care

Primary outcomes

  1. 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.

Secondary outcomes

  1. Change from Baseline sleep quality at 4 weeks

    Time frame: Baseline, week1, week2, week3, week4.

    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.

Sponsors and collaborators

Lead sponsor

Chung Shan Medical University

Other

Registry information

Official study title

Application of Schumann Resonance on Premature Infant

Important dates

Study start
2019
Primary completion
2021
Study completion
2021
First posted
Dec 7, 2021
Registry last updated
Dec 7, 2021

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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