Premature InfantNCT05557435
The Effect of Breast Milk Odor on Pain Response and Salivary Cortisol Level in Preterm Infants
A study testing breast milk odor in people with Premature Infant and Pain, run by Taipei Medical University.
Trial summary
The aims of this randomized controlled trial are investigate the effects of breast milk odor on pain response and saliva cortisol level duration heel stick blood sampling in preterm infants. Partipants will randomly assigned into the experimental group (breast milk odor) or control group (distilled water odor). Read more about this study
- Who is it for?
- Ages 0 to 10 days
- Conditions the study is for
- Premature Infant, Pain, Breast Milk Odor
- What is being tested?
- breast milk odor
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 64 participants
- Where
- No sites listed yet
- Study dates
- 1 Dec 2022to 30 Sep 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 0 to 10 days
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Premature babies whose gestational age is between 30 weeks to 36 weeks and six days, with a birth weight > 1000 grams.
- Apgar Score > 6 at 5 minutes of birth.
- Within 10 days of birth, the vital signs are stable.
- Those who have medical needs, such as blood monitoring of neonatal serum bilirubin, blood sugar, electrolyte, or neonatal screening, etc., need heel puncture blood sampling.
Who cannot join
- Those who have been diagnosed by a physician with severe congenital malformations, chromosomal abnormalities, respiratory distress, epilepsy, necrotizing enterocolitis, intracranial hemorrhage, periventricular leukomalacia, sepsis, meningitis, or hyperbilirubinemia.
- Those who have bronchopulmonary dysplasia or other chronic lung diseases that require the use of ventilator or non-invasive positive pressure respiratory support.
- Have used analgesics or anesthetics within 48 hours before giving the intervention of the study, or are participating in other studies that provide intervention for pain reduction.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: The Effect of Breast Milk Odor on Pain Response and Salivary Cortisol Level Duration Heel Stick Procedure in Preterm Infants: A Randomized Controlled Trial
The aims of this randomized controlled trial are investigate the effects of breast milk odor on pain response and saliva cortisol level duration heel stick blood sampling in preterm infants. Partipants will randomly assigned into the experimental group (breast milk odor) or control group (distilled water odor). The Premature Infant Pain Profile-Revised (PIPP-R) and Salimetrics® Cortisol Enzyme Immunoassay Kit are used to measuring the pain response and saliva cortisol level.
Read the detailed description
Preterm infants need to undergo more invasive medical interventions than full-term healthy newborns to maintain their lives. Physiological functions changes brought about by pain and stress stimulations may complicate nerve development in preterm infants. Therefore, providing positive sensory supportive interventions to reduce pain and stress is imperative for preterm infants. Studies have confirmed that the use of painkillers, breastfeeding, swaddling, kangaroo care, giving glucose or sucrose can help reduce pain. The sense of smell matures at 28 weeks of gestation age, and newborns can recognize the mother's smell after birth (Nishitani et al., 2009).
In recent years, several randomized studies have explored the effects of smell on reducing pain and stress in preterm infants, but the results are still inconclusive due to the lack of randomization blinding and a variety of smell interventions. It is desirable to plan a high-quality study. Although premature infants need to be separated from their mothers in nurseries due to medical needs, breast milk is still the best source of nutrition. The aims of this study are to investigate the effect of breast milk odor on pain response and saliva cortisol level duration heel stick blood sampling in preterm infants with gestation age at 30 to 37 weeks. A Randomized Controlled Trial will be designed. Preterm infants, who will receive heel sticks, are randomly assigned into the experimental group (breast milk odor) or control group (distilled water odor). The Premature Infant Pain Profile-Revised (PIPP-R) and Salimetrics® Cortisol Enzyme Immunoassay Kit are used to measuring the pain response and saliva cortisol level. Data will be analyzed by SPSS 22.0 (SPSS Inc., Chicago, IL, USA) using descriptive statistics, independent t-test, ANOVA, Generalized Estimating Equation linear multiple regression analysis… etc.
- Conditions
- Premature Infant, Pain, Breast Milk Odor
- Being tested
- breast milk odor, Placebo
- Keywords
- Breast Milk Odor, Pain, salivary cortisol, Preterm Infants, Randomized Controlled Trial
- Medical subject headings
- Premature Birth, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
breast milk odorOther
The intervention of the experimental group was to stimulate the odor of breast milk. The researchers informed the mothers of premature infants in advance on the day before the experiment, and collected the breast milk samples in the morning before eating on the day of the experiment (excluding the influence of the odor of breast milk by diet). The researchers took a clean cotton ball so that the breast milk was completely absorbed by the cotton ball, and placed the cotton ball that absorbed breast milk at a distance of 5cm next to the mouth and nose of the premature infant, so that the premature infant could receive the smell of breast milk.
The intervention of the control group was to stimulate the smell of distilled water.
PlaceboOther
Placebo
| Study group | Role | What they receive |
|---|---|---|
| Breast milk odor | Experimental | Participants received breast milk odor before and during heel stick. Receives: Other: breast milk odor |
| Placebo | Placebo comparator | Participants received placebo before and during heel stick. Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in pain on PIPP-R(Premature Infant Pain Profile - Revised, PIPP-R) in experimental group and control group from baseline and the time during heel stick.
PIPP-R is suitable for newborns from GA 25 to 41 weeks. The evaluation items include: two physiological indicators (heartbeat, blood oxygen), three behavioral indicators (frowning, closed eyes, facial expressions such as nasolabial folds), and two corrections factors (gestational weeks and behavioral status). Each item is scored on a scale of 0 to 3 on four scales. The full score varies according to the gestational week: 21 points up to 28 weeks, 20 points for 28 to 31+6 weeks, 19 points for 32 to 35+6 weeks, and 18 points for over 36 weeks. A total PIPP-R score of 6 or less indicates little or no pain, a score of 6 to 12 indicates mild to moderate pain, and a score greater than 12 indicates moderate to severe pain.
Measured: before heel stick [baseline] and during heel stick [5th minute].
Change in salivary cortisol in experimental group and control group from baseline to the time after heel stick.
Salimetrics® Cortisol Enzyme Immunoassay Kit Analytical sensitivity .Salivary cortisol samples in neonatal detection range: not detected to 3.41μg/dL.
Measured: before heel stick [baseline] and 25 minutes after heel stick [30th minute, reflecting pain and stress conditions at the moment of heel stick])
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2022
- Study start1 Dec 2022 (estimated)
- Primary completion1 Sep 2023 (estimated)
- Study completion30 Sep 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Premature InfantStudies of the same condition, open and under way.
- More trials run by Taipei Medical UniversityThe sponsor's other registered studies.
- 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
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 64 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Taipei Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05557435
- Sponsor's protocol ID
- N202204023
- Status last verified
- Sep 2022
- First submitted
- 20 Sep 2022
- Last updated
- 1 Dec 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Breast Milk Odor on Pain Response and Salivary Cortisol Level Duration Heel Stick Procedure in Preterm Infants: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05557435
- Acronym / sponsor ID
- N202204023
- Conditions
- Premature Infant, Pain, Breast Milk Odor
- Keywords
- Breast Milk Odor, Pain, salivary cortisol, Preterm Infants, Randomized Controlled Trial
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 64 participants (estimated)
- Lead sponsor
- Taipei Medical UniversityUniversity, hospital or other
- Study start
- 1 Dec 2022 (estimated)
- Primary completion
- 1 Sep 2023 (estimated)
- Study completion
- 30 Sep 2023 (estimated)
- First posted
- 28 Sep 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.
The aims of this randomized controlled trial are investigate the effects of breast milk odor on pain response and saliva cortisol level duration heel stick blood sampling in preterm infants. Partipants will randomly assigned into the experimental group (breast milk odor) or control group (distilled water odor). The Premature Infant Pain Profile-Revised (PIPP-R) and Salimetrics® Cortisol Enzyme Immunoassay Kit are used to measuring the pain response and saliva cortisol level.
Detailed description
Preterm infants need to undergo more invasive medical interventions than full-term healthy newborns to maintain their lives. Physiological functions changes brought about by pain and stress stimulations may complicate nerve development in preterm infants. Therefore, providing positive sensory supportive interventions to reduce pain and stress is imperative for preterm infants. Studies have confirmed that the use of painkillers, breastfeeding, swaddling, kangaroo care, giving glucose or sucrose can help reduce pain. The sense of smell matures at 28 weeks of gestation age, and newborns can recognize the mother's smell after birth (Nishitani et al., 2009).
In recent years, several randomized studies have explored the effects of smell on reducing pain and stress in preterm infants, but the results are still inconclusive due to the lack of randomization blinding and a variety of smell interventions. It is desirable to plan a high-quality study. Although premature infants need to be separated from their mothers in nurseries due to medical needs, breast milk is still the best source of nutrition. The aims of this study are to investigate the effect of breast milk odor on pain response and saliva cortisol level duration heel stick blood sampling in preterm infants with gestation age at 30 to 37 weeks. A Randomized Controlled Trial will be designed. Preterm infants, who will receive heel sticks, are randomly assigned into the experimental group (breast milk odor) or control group (distilled water odor). The Premature Infant Pain Profile-Revised (PIPP-R) and Salimetrics® Cortisol Enzyme Immunoassay Kit are used to measuring the pain response and saliva cortisol level. Data will be analyzed by SPSS 22.0 (SPSS Inc., Chicago, IL, USA) using descriptive statistics, independent t-test, ANOVA, Generalized Estimating Equation linear multiple regression analysis… etc.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Breast milk odor | Experimental | Other: breast milk odorParticipants received breast milk odor before and during heel stick. |
| Placebo | Placebo comparator | Other: PlaceboParticipants received placebo before and during heel stick. |
Who may qualify
- Ages
- 0 to 10 days
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Premature babies whose gestational age is between 30 weeks to 36 weeks and six days, with a birth weight > 1000 grams.
- Apgar Score > 6 at 5 minutes of birth.
- Within 10 days of birth, the vital signs are stable.
- Those who have medical needs, such as blood monitoring of neonatal serum bilirubin, blood sugar, electrolyte, or neonatal screening, etc., need heel puncture blood sampling.
Key exclusion criteria (3 listed)
- Those who have been diagnosed by a physician with severe congenital malformations, chromosomal abnormalities, respiratory distress, epilepsy, necrotizing enterocolitis, intracranial hemorrhage, periventricular leukomalacia, sepsis, meningitis, or hyperbilirubinemia.
- Those who have bronchopulmonary dysplasia or other chronic lung diseases that require the use of ventilator or non-invasive positive pressure respiratory support.
- Have used analgesics or anesthetics within 48 hours before giving the intervention of the study, or are participating in other studies that provide intervention for pain reduction.
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 |
|---|---|---|
| breast milk odorThe intervention of the experimental group was to stimulate the odor of breast milk. The researchers informed the mothers of premature infants in advance on the day before the experiment, and collected the breast milk samples in the morning before eating on the day of the experiment (excluding the influence of the odor of breast milk by diet). The researchers took a clean cotton ball so that the breast milk was completely absorbed by the cotton ball, and placed the cotton ball that absorbed breast milk at a distance of 5cm next to the mouth and nose of the premature infant, so that the premature infant could receive the smell of breast milk. The intervention of the control group was to stimulate the smell of distilled water. | Other | Breast milk odor |
| PlaceboPlacebo | Other | Placebo |
Primary outcome
Change in pain on PIPP-R(Premature Infant Pain Profile - Revised, PIPP-R) in experimental group and control group from baseline and the time during heel stick.
Time frame: before heel stick [baseline] and during heel stick [5th minute].
PIPP-R is suitable for newborns from GA 25 to 41 weeks. The evaluation items include: two physiological indicators (heartbeat, blood oxygen), three behavioral indicators (frowning, closed eyes, facial expressions such as nasolabial folds), and two corrections factors (gestational weeks and behavioral status). Each item is scored on a scale of 0 to 3 on four scales. The full score varies according to the gestational week: 21 points up to 28 weeks, 20 points for 28 to 31+6 weeks, 19 points for 32 to 35+6 weeks, and 18 points for over 36 weeks. A total PIPP-R score of 6 or less indicates little or no pain, a score of 6 to 12 indicates mild to moderate pain, and a score greater than 12 indicates moderate to severe pain.
Change in salivary cortisol in experimental group and control group from baseline to the time after heel stick.
Time frame: before heel stick [baseline] and 25 minutes after heel stick [30th minute, reflecting pain and stress conditions at the moment of heel stick])
Salimetrics® Cortisol Enzyme Immunoassay Kit Analytical sensitivity .Salivary cortisol samples in neonatal detection range: not detected to 3.41μg/dL.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Dec 2022.
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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.
Questions about this trial
What is this clinical trial studying?
A study testing breast milk odor in people with Premature Infant and Pain, run by Taipei Medical University.
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 3 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: status not confirmed, as of the sponsor's last update on 1 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Kee Hsin Chen, Ph.D (+886-2-2736-1661 ext. 3613, keehsin@tmu.edu.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in pain on PIPP-R(Premature Infant Pain Profile - Revised, PIPP-R) in experimental group and control group from baseline and the time during heel stick. (time frame: before heel stick [baseline] and during heel stick [5th minute].). The study lists 2 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 1 Dec 2022.