Very Low Birth Weight InfantNCT05406804
Olfactory Stimulation for Very Low Birth Weight Infants
A study testing Olfactory stimulation and Routine nursing care in people with Very Low Birth Weight Infant, run by Children's Hospital of Fudan University at 1 site in China.
Trial summary
This is a RCT study examining whether odor administration to mothers of very low birth weight infants promotes stabilization of vital signs compared with common nursing care. This study used breast milk olfactory stimuli familiar and liked by premature infants to understand the effects of olfactory stimuli on the… Read more about this study
- Who is it for?
- Ages 0 to 24 hours
- Conditions the study is for
- Very Low Birth Weight Infant
- What is being tested?
- Olfactory stimulation and Routine nursing care
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- 1 Jul 2020to 31 Oct 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 0 to 24 hours
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Gestational age at birth <32 weeks;
- Birth weight < 1500 g;
- Admission to hospital within 24 hours after birth;
- Mother can provide breast milk
Who cannot join
- Severe congenital malformations;
- Complicated congenital heart disease;
- Congenital gastrointestinal disease;
- Intraventricular hemorrhage
Trial locations and contacts
1 site in 1 country.
China1 site
Children's Hospital of Fudan University
Shanghai, Shanghai Municipality, 201102
About this study
Official title: The Influence of Olfactory Stimulation of Breast Milk on the Stability of Physiological Indicators of Very Low Birth Weight Infants
This is a RCT study examining whether odor administration to mothers of very low birth weight infants promotes stabilization of vital signs compared with common nursing care. This study used breast milk olfactory stimuli familiar and liked by premature infants to understand the effects of olfactory stimuli on the physiological indicators of very low birth weight infants, the effect on the time of complete enteral nutrition, and the effects on growth and development of very low birth weight infants.
Read the detailed description
Fluctuations in vital signs of very low birth weight infants may lead to poor prognosis. Research Objectives:
To evaluate the effect of olfactory stimulation of breast milk on the stability of physiological indexes of very low birth weight infants Subjects: Very low birth weight infants whose gestational age are less than 32 weeks.
- Conditions
- Very Low Birth Weight Infant
- Being tested
- Olfactory stimulation, Routine nursing care
- Keywords
- Olfactory stimulation, Heart rate, Oxygen saturation, Respiratory rate
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Olfactory stimulationBehavioural
- For the premature infants who use non-invasive ventilation, place a single layer of gauze soaked in breast milk on the air outlet of the non-invasive ventilator. When inhaling oxygen with a high-flow nasal cannula, the same measure is performed, and the breast milk and sterile gauze soaked in breast milk are replaced every 4 hours. 2) For the premature infants who withdrawn from assisted ventilation, place the breast pad near the infants' nose, and replace the breast milk pad every 4 hours. Acquisition of breast milk pads: use the same brand of breast milk pads; put the breast milk pads used between 00:00 and 07:00 every day (use time > 2 hours) into the same brand of milk storage bags, and use two left and right at the same time. 3) If the premature infants don't have any ventilation support, the breast milk stimulation method is the same as 2). This intervention will continue until premature infants discharge from hospital.
Routine nursing careBehavioural
Nursing is performed according to existing nursing practices. Nasal feeding is generally used.
| Study group | Role | What they receive |
|---|---|---|
| Breast milk olfactory stimulation care | Experimental | Let premature babies smell their mother's breast milk Receives: Behavioral: Olfactory stimulation |
| Routine care | Active comparator | Prevent premature babies from smelling their mother's breast milk Receives: Behavioral: Routine nursing care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ratio of stable heart rate
During the intervention period, the frequency of the measured heart rate between 120 bpm and 160bpm divide the total frequency of heart rate monitoring. The heart rate, blood oxygen saturation and other data will be automatically uploaded to the system by the electrocardiogram monitor every minute, one for each one every minute, which is downloaded by the researcher and then entered into the computer.
Measured: During the procedure.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jun 2022
- Study start1 Jul 2020
- Primary completion31 Oct 2021
- Study completion31 Oct 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Very Low Birth Weight InfantStudies 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Children's Hospital of Fudan University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05406804
- Sponsor's protocol ID
- NICU olfactory stimulation-01
- Status last verified
- Apr 2022
- First submitted
- 14 Feb 2022
- Last updated
- 6 Jun 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Yu L, Tao Y, Jia P, Li L, Lv T, Wang L, Song Q, Huan X, Liu C, Dou Y, Xuan Y, Hu XJ. Effect of breast milk olfactory experience on physiological indicators in very low birth weight infants: a randomized clinical trial. Sci Rep. 2025 Jul 1;15(1):20590. doi: 10.1038/s41598-025-05809-0.
PubMed 40596001
Study at a glance
From the registry record, last updated by the sponsor on 6 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Influence of Olfactory Stimulation of Breast Milk on the Stability of Physiological Indicators of Very Low Birth Weight Infants
- ClinicalTrials.gov ID
- NCT05406804
- Acronym / sponsor ID
- NICU olfactory stimulation-01
- Conditions
- Very Low Birth Weight Infant
- Keywords
- Olfactory stimulation, Heart rate, Oxygen saturation, Respiratory rate
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Children's Hospital of Fudan UniversityUniversity, hospital or other
- Study start
- 1 Jul 2020 (actual)
- Primary completion
- 31 Oct 2021 (actual)
- Study completion
- 31 Oct 2021 (actual)
- First posted
- 6 Jun 2022 (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 RCT study examining whether odor administration to mothers of very low birth weight infants promotes stabilization of vital signs compared with common nursing care. This study used breast milk olfactory stimuli familiar and liked by premature infants to understand the effects of olfactory stimuli on the physiological indicators of very low birth weight infants, the effect on the time of complete enteral nutrition, and the effects on growth and development of very low birth weight infants.
Detailed description
Fluctuations in vital signs of very low birth weight infants may lead to poor prognosis. Research Objectives:
To evaluate the effect of olfactory stimulation of breast milk on the stability of physiological indexes of very low birth weight infants Subjects: Very low birth weight infants whose gestational age are less than 32 weeks.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Breast milk olfactory stimulation care | Experimental | Behavioral: Olfactory stimulationLet premature babies smell their mother's breast milk |
| Routine care | Active comparator | Behavioral: Routine nursing carePrevent premature babies from smelling their mother's breast milk |
Who may qualify
- Ages
- 0 to 24 hours
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Gestational age at birth <32 weeks;
- Birth weight < 1500 g;
- Admission to hospital within 24 hours after birth;
- Mother can provide breast milk
Key exclusion criteria (4 listed)
- Severe congenital malformations;
- Complicated congenital heart disease;
- Congenital gastrointestinal disease;
- Intraventricular hemorrhage
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 |
|---|---|---|
| Olfactory stimulation1) For the premature infants who use non-invasive ventilation, place a single layer of gauze soaked in breast milk on the air outlet of the non-invasive ventilator. When inhaling oxygen with a high-flow nasal cannula, the same measure is performed, and the breast milk and sterile gauze soaked in breast milk are replaced every 4 hours. 2) For the premature infants who withdrawn from assisted ventilation, place the breast pad near the infants' nose, and replace the breast milk pad every 4 hours. Acquisition of breast milk pads: use the same brand of breast milk pads; put the breast milk pads used between 00:00 and 07:00 every day (use time > 2 hours) into the same brand of milk storage bags, and use two left and right at the same time. 3) If the premature infants don't have any ventilation support, the breast milk stimulation method is the same as 2). This intervention will continue until premature infants discharge from hospital. | Behavioural | Breast milk olfactory stimulation care |
| Routine nursing careNursing is performed according to existing nursing practices. Nasal feeding is generally used. | Behavioural | Routine care |
Primary outcome
Ratio of stable heart rate
Time frame: During the procedure.
During the intervention period, the frequency of the measured heart rate between 120 bpm and 160bpm divide the total frequency of heart rate monitoring. The heart rate, blood oxygen saturation and other data will be automatically uploaded to the system by the electrocardiogram monitor every minute, one for each one every minute, which is downloaded by the researcher and then entered into the computer.
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 6 Jun 2022.
- Derived from this study: PubMed 40596001Yu L, Tao Y, Jia P, Li L, Lv T, Wang L, Song Q, Huan X, Liu C, Dou Y, Xuan Y, Hu XJ. Effect of breast milk olfactory experience on physiological indicators in very low birth weight infants: a randomized clinical trial. Sci Rep. 2025 Jul 1;15(1):20590. doi: 10.1038/s41598-025-05809-0.
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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 Olfactory stimulation and Routine nursing care in people with Very Low Birth Weight Infant, run by Children's Hospital of Fudan University 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 4 inclusion and 4 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 6 Jun 2022. 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?
Ratio of stable heart rate (time frame: During the procedure.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05406804, which also lists 1 linked publication.
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 6 Jun 2022.