BreastfeedingNCT07127679
The Effect of Breast Milk on Pain and Stress
A study testing Two minutes before the ROP examination, 2 mL of freshly expressed breast milk was administered to infants in the experimental group using a syringe, placing the milk on the front of the tongue. As par in people with Breastfeeding and Retinopaty of Prematurity, run by Ege University at 1 site in Turkey (Türkiye).
Trial summary
This study aimed to examine the effect of breast milk on pain and stress during Retinopathy of Prematurity (ROP) examinations. This randomized controlled experimental study was conducted with premature infants (N = 154) hospitalized in the Department of Child Health and Diseases, Neonatology Unit, at Izmir Ege… Read more about this study
- Who is it for?
- Ages 30 to 34 weeks
- Conditions the study is for
- Breastfeeding, Retinopaty of Prematurity, Pain
- What is being tested?
- Two minutes before the ROP examination, 2 mL of freshly expressed breast milk was administered to infants in the experimental group using a syringe, placing the milk on the front of the tongue. As par
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Feb 2024to 1 Mar 2025
- 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 30 to 34 weeks
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- The baby's birth week is ≤34 or birth weight is ≤1700 grams, room babies who are monitored in good mood and have good clinical findings
- Babies who have developed sucking and swallowing skills and can hold a pacifier
- Any analgesic, muscle relaxant and sedative that may affect the pain level not taking effective medication
- The family agrees to participate in the study.
- Babies are in neonatal intensive care
- Having babies who are exclusively breastfed
- First ROP examination
Who cannot join
- Babies with congenital anomalies and metabolic diseases, cleft palate and cleft babies with lips did not sign the informed consent form and did not participate in the study.
- Babies from families that did not accept were not included in the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Breast Milk on Pain and Stress During Retinopathy of Prematurity Examination
This study aimed to examine the effect of breast milk on pain and stress during Retinopathy of Prematurity (ROP) examinations. This randomized controlled experimental study was conducted with premature infants (N = 154) hospitalized in the Department of Child Health and Diseases, Neonatology Unit, at Izmir Ege University Faculty of Medicine Hospital between February 2024 and January 2025. A total of 36 premature infants (experimental group: 18; control group: 18) who met the inclusion criteria were included in the study. Data were collected using the Infant Information Form, the Premature Infant Pain Profile (PIPP), and the Neonatal Stress Scale. Two minutes before the ROP examination, 2 mL of freshly expressed breast milk was administered to infants in the experimental group using a syringe, placing the milk on the front of the tongue. Breast milk may be effective in reducing pain and stress associated with ROP examinations.
Keywords: Retinopathy of Prematurity; ROP; Breast Milk; Pain; Stress
Read the detailed description
This study aimed to examine the effect of breast milk on pain and stress during Retinopathy of Prematurity (ROP) examinations. This randomized controlled experimental study was conducted with premature infants (N = 154) hospitalized in the Department of Child Health and Diseases, Neonatology Unit, at Izmir Ege University Faculty of Medicine Hospital between February 2024 and January 2025. A total of 36 premature infants (experimental group: 18; control group: 18) who met the inclusion criteria were included in the study. Data were collected using the premature infant information form, the premature infant vital signs record form, the Premature Infant Pain Profile (PIPP), and the Neonatal Stress Scale. Two minutes before the ROP examination, 2 mL of freshly expressed breast milk was administered to infants in the experimental group using a syringe, placing the milk on the front of the tongue. As part of routine care, all infants were swaddled and given a pacifier before the procedure. Video recording began 3 minutes prior to the ROP examination and continued until the infant stopped crying post-examination. Recordings were assessed by two independent observers to determine pain and stress scores, as well as parameters such as heart rate, oxygen saturation, perfusion index, and duration of crying.
The study found that pain scores were significantly lower in the group that received breast milk prior to the ROP examination compared to the control group (p <0.001). Stress scores were also significantly lower in the breast milk group (p < 0.001).The breast milk group showed more favorable oxygen saturation and heart rate levels (p < 0.05). There was no significant difference in perfusion index between the two groups. Crying duration was significantly shorter in the breast milk group compared to the control group (p < 0.001). Breast milk may be effective in reducing pain and stress associated with Retinopathy of Prematurity examinations.
- Conditions
- Breastfeeding, Retinopaty of Prematurity, Pain, Stress
- Being tested
- Two minutes before the ROP examination, 2 mL of freshly expressed breast milk was administered to infants in the experimental group using a syringe, placing the milk on the front of the tongue. As par
- Keywords
- Retinopathy of Prematurity, ROP, Breast Milk, Pain, Stress
- Medical subject headings
- Breast Feeding, Pain, Retinopathy of Prematurity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Two minutes before the ROP examination, 2 mL of freshly expressed breast milk was administered to infants in the experimental group using a syringe, placing the milk on the front of the tongue. As parOther
Data were collected using the premature infant information form, the premature infant vital signs record form, the Premature Infant Pain Profile (PIPP), and the Neonatal Stress Scale. Two minutes before the ROP examination, 2mL of freshly expressed breast milk was administered to infants in the experimental group using a syringe, placing the milk on the front of the tongue. As part of routine care, all infants were swaddled and given a pacifier before the procedure. Video recording began 3 minutes prior to the ROP examination and continued until the infant stopped crying post-examination. Recordings were assessed by two independent observers to determine pain and stress scores, as well as parameters such as heart rate, oxygen saturation, perfusion index, and duration of crying.
| Study group | Role | What they receive |
|---|---|---|
| breast milk group | Experimental | Two minutes before the ROP examination, 2mL of freshly expressed breast milk was administered to infants in the experimental group using a syringe, placing the milk on the front of the tongue. As part of routine care, all infants were swaddled and given a pacifier before the procedure. Video recording began 3 minutes prior to the ROP examination and continued until the infant stopped crying post-examination. Receives: Other: Two minutes before the ROP examination, 2 mL of freshly expressed breast milk was administered to infants in the experimental group using a syringe, placing the milk on the front of the tongue. As par |
| control group | No intervention | As part of routine care, all infants were swaddled and given a pacifier before the procedure. Video recording began 3 minutes prior to the ROP examination and continued until the infant stopped crying post-examination. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Premature Infant Pain Profile (PIPP),
The Premature Infant Pain Profile (PIPP) is a behavioral measure of pain for premature infants. It was developed at the Universities of Toronto and McGill in Canada. Minimum score: 0, maximum score: 21.The higher the score the greater the pain behavior.The PIPP is a 7-item multidimensional (composite) measure of pain that has been used widely to assess acute pain in infants. The PIPP includes 3 behavioral (facial actions: brow bulge, eye squeeze, nasolabial furrow), 2 physiological (heart rate and oxygen saturation), and 2 contextual (gestational age [GA] and behavioral state [BS]) items.
Measured: one week
Neonatal Stress Scale
This scale is used in premature babies. It was prepared to evaluate stress. 8 subgroups (facial expression, body color, breathing, activity level, consolability, muscle tone, extremities, posture). The form consisting of 24 items is a 3-point Likert type. In the preparation of the draft form, the principles included in the Synactive Theory created within the framework of concepts.
Each subgroup is scored between 0 and 2. The maximum score on the scale is 16, and the minimum is 0. A score of 0 indicates that the baby is not stressed. The higher the score, the higher the baby's stress level.
Measured: one week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Aug 2025
- Study start1 Feb 2024
- Primary completion1 Jan 2025
- Study completion1 Mar 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for BreastfeedingStudies of the same condition, open and under way.
- More trials run by Ege 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
- None (open label)
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ege University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Emel BULDUR, Ege University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07127679
- Sponsor's protocol ID
- 1462/1442
- Status last verified
- Aug 2025
- First submitted
- 7 Aug 2025
- Last updated
- 17 Aug 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 17 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Breast Milk on Pain and Stress During Retinopathy of Prematurity Examination
- ClinicalTrials.gov ID
- NCT07127679
- Acronym / sponsor ID
- 1462/1442
- Conditions
- Breastfeeding, Retinopaty of Prematurity, Pain, Stress
- Keywords
- Retinopathy of Prematurity, ROP, Breast Milk, Pain, Stress
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Ege UniversityUniversity, hospital or other
- Study start
- 1 Feb 2024 (actual)
- Primary completion
- 1 Jan 2025 (actual)
- Study completion
- 1 Mar 2025 (actual)
- First posted
- 17 Aug 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.
This study aimed to examine the effect of breast milk on pain and stress during Retinopathy of Prematurity (ROP) examinations. This randomized controlled experimental study was conducted with premature infants (N = 154) hospitalized in the Department of Child Health and Diseases, Neonatology Unit, at Izmir Ege University Faculty of Medicine Hospital between February 2024 and January 2025. A total of 36 premature infants (experimental group: 18; control group: 18) who met the inclusion criteria were included in the study. Data were collected using the Infant Information Form, the Premature Infant Pain Profile (PIPP), and the Neonatal Stress Scale. Two minutes before the ROP examination, 2 mL of freshly expressed breast milk was administered to infants in the experimental group using a syringe, placing the milk on the front of the tongue. Breast milk may be effective in reducing pain and stress associated with ROP examinations.
Keywords: Retinopathy of Prematurity; ROP; Breast Milk; Pain; Stress
Detailed description
This study aimed to examine the effect of breast milk on pain and stress during Retinopathy of Prematurity (ROP) examinations. This randomized controlled experimental study was conducted with premature infants (N = 154) hospitalized in the Department of Child Health and Diseases, Neonatology Unit, at Izmir Ege University Faculty of Medicine Hospital between February 2024 and January 2025. A total of 36 premature infants (experimental group: 18; control group: 18) who met the inclusion criteria were included in the study. Data were collected using the premature infant information form, the premature infant vital signs record form, the Premature Infant Pain Profile (PIPP), and the Neonatal Stress Scale. Two minutes before the ROP examination, 2 mL of freshly expressed breast milk was administered to infants in the experimental group using a syringe, placing the milk on the front of the tongue. As part of routine care, all infants were swaddled and given a pacifier before the procedure. Video recording began 3 minutes prior to the ROP examination and continued until the infant stopped crying post-examination. Recordings were assessed by two independent observers to determine pain and stress scores, as well as parameters such as heart rate, oxygen saturation, perfusion index, and duration of crying.
The study found that pain scores were significantly lower in the group that received breast milk prior to the ROP examination compared to the control group (p <0.001). Stress scores were also significantly lower in the breast milk group (p < 0.001).The breast milk group showed more favorable oxygen saturation and heart rate levels (p < 0.05). There was no significant difference in perfusion index between the two groups. Crying duration was significantly shorter in the breast milk group compared to the control group (p < 0.001). Breast milk may be effective in reducing pain and stress associated with Retinopathy of Prematurity examinations.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| breast milk group | Experimental | Other: Two minutes before the ROP examination, 2 mL of freshly expressed breast milk was administered to infants in the experimental group using a syringe, placing the milk on the front of the tongue. As parTwo minutes before the ROP examination, 2mL of freshly expressed breast milk was administered to infants in the experimental group using a syringe, placing the milk on the front of the tongue. As part of routine care, all infants were swaddled and given a pacifier before the procedure. Video recording began 3 minutes prior to the ROP examination and continued until the infant stopped crying post-examination. |
| control group | No intervention | –As part of routine care, all infants were swaddled and given a pacifier before the procedure. Video recording began 3 minutes prior to the ROP examination and continued until the infant stopped crying post-examination. |
Who may qualify
- Ages
- 30 to 34 weeks
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (7 listed)
- The baby's birth week is ≤34 or birth weight is ≤1700 grams, room babies who are monitored in good mood and have good clinical findings
- Babies who have developed sucking and swallowing skills and can hold a pacifier
- Any analgesic, muscle relaxant and sedative that may affect the pain level not taking effective medication
- The family agrees to participate in the study.
- Babies are in neonatal intensive care
Key exclusion criteria (2 listed)
- Babies with congenital anomalies and metabolic diseases, cleft palate and cleft babies with lips did not sign the informed consent form and did not participate in the study.
- Babies from families that did not accept were not included in the study.
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 |
|---|---|---|
| Two minutes before the ROP examination, 2 mL of freshly expressed breast milk was administered to infants in the experimental group using a syringe, placing the milk on the front of the tongue. As parData were collected using the premature infant information form, the premature infant vital signs record form, the Premature Infant Pain Profile (PIPP), and the Neonatal Stress Scale. Two minutes before the ROP examination, 2mL of freshly expressed breast milk was administered to infants in the experimental group using a syringe, placing the milk on the front of the tongue. As part of routine care, all infants were swaddled and given a pacifier before the procedure. Video recording began 3 minutes prior to the ROP examination and continued until the infant stopped crying post-examination. Recordings were assessed by two independent observers to determine pain and stress scores, as well as parameters such as heart rate, oxygen saturation, perfusion index, and duration of crying. | Other | breast milk group |
Primary outcome
Premature Infant Pain Profile (PIPP),
Time frame: one week
The Premature Infant Pain Profile (PIPP) is a behavioral measure of pain for premature infants. It was developed at the Universities of Toronto and McGill in Canada. Minimum score: 0, maximum score: 21.The higher the score the greater the pain behavior.The PIPP is a 7-item multidimensional (composite) measure of pain that has been used widely to assess acute pain in infants. The PIPP includes 3 behavioral (facial actions: brow bulge, eye squeeze, nasolabial furrow), 2 physiological (heart rate and oxygen saturation), and 2 contextual (gestational age [GA] and behavioral state [BS]) items.
Neonatal Stress Scale
Time frame: one week
This scale is used in premature babies. It was prepared to evaluate stress. 8 subgroups (facial expression, body color, breathing, activity level, consolability, muscle tone, extremities, posture). The form consisting of 24 items is a 3-point Likert type. In the preparation of the draft form, the principles included in the Synactive Theory created within the framework of concepts. Each subgroup is scored between 0 and 2. The maximum score on the scale is 16, and the minimum is 0. A score of 0 indicates that the baby is not stressed. The higher the score, the higher the baby's stress level.
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 17 Aug 2025.
- Individual participant dataSharing planned: Undecided
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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 Two minutes before the ROP examination, 2 mL of freshly expressed breast milk was administered to infants in the experimental group using a syringe, placing the milk on the front of the tongue. As par in people with Breastfeeding and Retinopaty of Prematurity, run by Ege University at 1 site in Turkey (Türkiye).
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 7 inclusion and 2 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 17 Aug 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 Turkey (Türkiye). 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?
Premature Infant Pain Profile (PIPP), (time frame: one week). 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 17 Aug 2025.