PreTerm NeonateNCT07187232
Effects of Acupressure on Physiological Indicators, Oxygen Demand and Length of Hospital Stay in Premature Infants With Pulmonary Infiltration
A study testing massage acupoints and Routine care in people with PreTerm Neonate and Pulmonary Complications, run by Changhua Christian Hospital at 1 site in Taiwan.
Trial summary
In 2020, 11.6% of newborns are delivered prematurely in Taiwan. Excessive sputum is a common symptom of respiratory complications in premature infants. Effective methods for reducing sputum secretion in premature infants need to be urgently explored. Read more about this study
- Who is it for?
- Ages 32 weeks and olderHealthy volunteers can take part
- Conditions the study is for
- PreTerm Neonate, Pulmonary Complications
- What is being tested?
- massage acupoints and Routine care
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 42 participants
- Where
- 1 siteTaiwan
- Study dates
- 2 Jul 2023to 30 Jun 2024
- 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 32 weeks and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Newborn ≤32 weeks of gestational age
- X-ray reporting pulmonary infiltration requiring suctioning
- Treated with O2 nasal cannula or High-flow nasal cannula
Who cannot join
- Congenital pulmonary structural abnormalities
- Muscular weakness
- Heart disease, excluding Patent Ductus Arteriosus(PDA) and Atrial Septal Defect (ASD)
- Abnormal bleeding conditions
- Chest tube placement
- Compromised skin integrity at the acupressure sites
Trial locations and contacts
1 site in 1 country.
About this study
In 2020, 11.6% of newborns are delivered prematurely in Taiwan. Excessive sputum is a common symptom of respiratory complications in premature infants. Effective methods for reducing sputum secretion in premature infants need to be urgently explored.
- Conditions
- PreTerm Neonate, Pulmonary Complications
- Being tested
- massage acupoints, Routine care
- Keywords
- Acupressure, Preterm Infants, Pulmonary Infiltration, Suction Frequency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
massage acupointsBehavioural
The massage acupoints involved Zusanli (ST36), Fenglong (ST40), Zhongfu (LU1), Tanzhong (CV17), and Feishu (BL13). Each acupoint was massaged for 2 minutes, totaling 10 minutes per session. The routine care included chest physiotherapy and sputum suction as needed every 3 hours (PRN, Q3H).
Routine careBehavioural
The routine care included chest physiotherapy and sputum suction as needed every 3 hours (PRN, Q3H).
| Study group | Role | What they receive |
|---|---|---|
| Acupressure | Experimental | Not described Receives: Behavioral: massage acupoints |
| Routine care | Placebo comparator | Not described Receives: Behavioral: Routine care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Frequency of sputum suction
Suctioning frequency per day was obtained from nursing records throughout the intervention period and for the subsequent two days.
Measured: The study outcomes were evaluated before and day 5, day 10, day 12 after the intervention.
Secondary outcomes (1)
Physiological indicatores
Physiological indicators include heart rate、 respiratory rate、 oxygen saturation.
Physiological indicators per day was obtained from nursing records throughout the intervention period and for the subsequent two days on physiological chart record sheets.
- Heart Rate Description: Daily heart rate obtained from nursing records. Unit of measure: beats per minute (bpm). Measured instruments: Philips MX450 ECG Monitor.
- Respiratory Rate Description: Daily respiratory rate obtained from nursing records. Unit of measure: breaths per minute. Measured instruments: Philips MX450 ECG Monitor.
- Oxygen Saturation (SpO₂) Description: Daily oxygen saturation obtained from nursing records. Unit of measure: percentage (%). Measured instruments: Philips MX450 ECG Monitor.
Measured: These outcomes were recorded 2 days before the intervention, days 1-5 of the intervention, days 6-10 of the intervention, and 2 days after the intervention.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2025
- Study start2 Jul 2023
- Primary completion11 Apr 2024
- Study completion30 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PreTerm NeonateStudies 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
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- Changhua Christian Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07187232
- Sponsor's protocol ID
- 221235
- Status last verified
- Sep 2025
- First submitted
- 26 Jun 2025
- Last updated
- 22 Sep 2025
- 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 22 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Acupressure on Physiological Indicators, Oxygen Demand and Length of Hospital Stay in Premature Infants With Pulmonary Infiltration
- ClinicalTrials.gov ID
- NCT07187232
- Acronym / sponsor ID
- 221235
- Conditions
- PreTerm Neonate, Pulmonary Complications
- Keywords
- Acupressure, Preterm Infants, Pulmonary Infiltration, Suction Frequency
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Changhua Christian HospitalUniversity, hospital or other
- Study start
- 2 Jul 2023 (actual)
- Primary completion
- 11 Apr 2024 (actual)
- Study completion
- 30 Jun 2024 (actual)
- First posted
- 22 Sep 2025 (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.
In 2020, 11.6% of newborns are delivered prematurely in Taiwan. Excessive sputum is a common symptom of respiratory complications in premature infants. Effective methods for reducing sputum secretion in premature infants need to be urgently explored.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Acupressure | Experimental | Behavioral: massage acupoints |
| Routine care | Placebo comparator | Behavioral: Routine care |
Who may qualify
- Ages
- 32 weeks and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Newborn ≤32 weeks of gestational age
- X-ray reporting pulmonary infiltration requiring suctioning
- Treated with O2 nasal cannula or High-flow nasal cannula
Key exclusion criteria (6 listed)
- Congenital pulmonary structural abnormalities
- Muscular weakness
- Heart disease, excluding Patent Ductus Arteriosus(PDA) and Atrial Septal Defect (ASD)
- Abnormal bleeding conditions
- Chest tube placement
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 |
|---|---|---|
| massage acupointsThe massage acupoints involved Zusanli (ST36), Fenglong (ST40), Zhongfu (LU1), Tanzhong (CV17), and Feishu (BL13). Each acupoint was massaged for 2 minutes, totaling 10 minutes per session. The routine care included chest physiotherapy and sputum suction as needed every 3 hours (PRN, Q3H). | Behavioural | Acupressure |
| Routine careThe routine care included chest physiotherapy and sputum suction as needed every 3 hours (PRN, Q3H). | Behavioural | Routine care |
Primary outcome
Frequency of sputum suction
Time frame: The study outcomes were evaluated before and day 5, day 10, day 12 after the intervention.
Suctioning frequency per day was obtained from nursing records throughout the intervention period and for the subsequent two days.
1 secondary outcome
Physiological indicatores
Time frame: These outcomes were recorded 2 days before the intervention, days 1-5 of the intervention, days 6-10 of the intervention, and 2 days after the intervention.
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 22 Sep 2025.
- Individual participant dataSharing planned: No
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NEC - Necrotizing Enterocolitis
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Optimization of Saturation Targets And Resuscitation Trial (OptiSTART)
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Growing Little PEAPODS Study
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REspiratory MEchanics for Delivering Individualised Exogenous Surfactant
Respiratory Distress Syndrome in Premature Infant
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 massage acupoints and Routine care in people with PreTerm Neonate and Pulmonary Complications, run by Changhua Christian Hospital 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 3 inclusion and 6 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 22 Sep 2025. 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. Some participants in this study may receive a placebo. 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?
Frequency of sputum suction (time frame: The study outcomes were evaluated before and day 5, day 10, day 12 after the intervention.). 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 22 Sep 2025.