Newborn CareNCT07716813
The Effect of Breast Milk, 10% and 20% Dextrose on Pain and Physiological Variables During Heel Puncture in Infants
A study testing Administering oral breast milk in a supportive position, Administering oral 10% dextrose in a supportive position and Administering oral 20% dextrose in a supportive position in people with Newborn Care and Pain Management, run by Mersin University at 1 site in Turkey (Türkiye).
Trial summary
Pain, defined by the International Association for the Study of Pain as a subjective, sensory, and emotional experience, differs from nociception, which is merely a neural activity. Read more about this study
- Who is it for?
- Ages 32 weeks to 37 months
- Conditions the study is for
- Newborn Care, Pain Management, Physiological Parameters During Newborn Care İn Newborn's
- What is being tested?
- Administering oral breast milk in a supportive position, Administering oral 10% dextrose in a supportive position and Administering oral 20% dextrose in a supportive position
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 96 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 18 Jun 2026to 30 Nov 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 to 37 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Parental consent for the baby's participation in the study
- Admission to Mersin University Hospital NICU between July 16, 2026 and December 30, 2026,
- Gestational age at birth between 33 weeks and 37 weeks,
- Postnatal age less than 7 days,
- Heel prick blood test planned within the scope of NTP,
- Stable clinical condition,
Show all 16Show fewer
- Absence of genetic or metabolic problems,
- Developed sucking-swallowing and breathing coordination,
- Having been fed at least 30 minutes before the procedure,
- No experience with invasive procedures in the last 6 hours before the procedure,
- No administration of non-opioid analgesics in the last 4 hours before the procedure,
- No administration of opioid analgesics and sedative agents in the last 24 hours before the procedure,
- Spontaneous respiration at 21% FiO2,
- Absence of neurological problems (e.g., asphyxia, hypoxic ischemic encephalopathy, intraventricular hemorrhage, periventricular leukomalacia, spinal cord injury…),
- Absence of contraindications to oral glucose/breast milk administration (e.g., necrotizing enterocolitis or suspicion thereof, feeding intolerance, tracheoesophageal fistula, absence of esophageal atresia…),
- Absence of endocrine problems (e.g., hypoglycemia, hyperglycemia, large for gestational age, absence of a diabetic mother…),
Who cannot join
- Parental disapproval of infant's participation in the study
- No hospitalization at Mersin University Hospital NICUs between July 16, 2026 and December 30, 2026,
- Gestational age at birth less than 33 weeks or greater than 37 weeks,
- Postnatal age greater than 7 days,
- Heel prick blood test not planned within the scope of NTP,
- Clinical condition not stable,
Show all 16Show fewer
- Lack of developed sucking-swallowing and breathing coordination,
- Having been fed within 30 minutes of the procedure,
- Having had invasive procedures experience in the last 6 hours before the procedure,
- Having received non-opioid analgesics in the last 4 hours before the procedure,
- Having received opioid analgesics and sedative agents in the last 24 hours before the procedure,
- Genetic or metabolic problem The following are contraindications:
- Being on invasive or non-invasive mechanical ventilation support,
- Having a neurological problem,
- Oral glucose/breast milk administration being contraindicated,
- Having an endocrine and metabolic problem.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Mersin University
Mersin, 33343
Ozlem Guzel Polat, 1, +905067685660, ozlemgzl@mersin.edu.tr
Derya Akdeniz Uysal, 2, dryknz81@gmail.com
About this study
Official title: The Effect of Oral Breast Milk and 20% Dextrose Solution Administered With Supportive Positioning Methods on Pain and Physiological Variables During Heel Puncture Blood Sampling in Preterm Infants: A Randomized Controlled Trial
Pain, defined by the International Association for the Study of Pain as a subjective, sensory, and emotional experience, differs from nociception, which is merely a neural activity. Premature newborns, whose inhibitory fibers are not yet mature due to anatomical and physiological development and who have insufficient endogenous opioid release, experience painful stimuli much more intensely. The inability of this age group to verbally express pain makes the diagnosis, assessment, and management of pain entirely dependent on healthcare professionals. Pain that is not effectively managed leads to stress and loss of comfort in the short term, while in the long term it can cause permanent neurodevelopmental problems and alter the individual's pain threshold later in life.
Premature infants, especially those in Neonatal Intensive Care Units (NICUs), are exposed to invasive procedures that cause moderate to severe pain, such as heel prick tests, much more frequently than healthy term infants. In this context, pain management is a fundamental and essential nursing responsibility for the infant's neuroprotective developmental care. The literature shows that various non-pharmacological methods, such as oral sucrose, non-nutritive sucking (NNS), facilitated flexion, and wrapping, are used to alleviate pain during interventional procedures. Although more readily available in NICUs, studies on the effectiveness of oral glucose solutions are more limited compared to sucrose.
This research, designed to address this gap in the existing literature, aims to investigate the effect of "oral breast milk, 20%, and 10% dextrose solution administered with supportive positioning methods" on pain reduction during heel prick blood sampling in premature newborns. The results of this research are expected to contribute to the development of a new, easily applicable, effective, and evidence-based nursing intervention strategy for NICUs.
Read the detailed description
Aim: This study aims to determine the primary effect of oral breast milk, 20% dextrose, and 10% dextrose solutions-administered alongside supportive positioning methods during routine heel lancing blood sampling (within the Neonatal Screening Program)-on pain scores in premature newborns admitted to the NICUs. Secondarily, it aims to evaluate the effects of these interventions on heart rate and oxygen saturation variables.
Hypotheses: The research hypothesizes that there is a statistically significant difference between the oral breast milk, 20% dextrose, and 10% dextrose solution groups (applied with supportive positioning) regarding pain scores (H1a), heart rate (H1b), and oxygen saturation levels (H1c) during the heel lancing procedure.
Study Design: The study will be conducted using a single-center, parallel-group, randomized controlled trial design.
Study Location: The research will take place in the Neonatal Intensive Care Unit of Mersin University Hospital.
NICUs Characteristics: The unit features a traditional open-bay design comprising two wards. It provides level 4a care and has a total incubator capacity of 27.
Work Environment and Care Approach: As a tertiary referral center, the NICUs operates on two shifts (08:00-16:00 and 16:00-08:00), with a nurse-to-infant ratio ranging from 1:1 to 1:3. The unit adopts a family-centered individualized developmental care approach. The Turkish version of the Neonatal Pain, Agitation, and Sedation Scale (N-PASS) is routinely used to evaluate and record pain scores during shift changes and interventional procedures.
Study Population: The study population will consist of premature newborns admitted to the Mersin University Hospital NICU who are scheduled for routine heel prick blood sampling.
Sample Size: The sample size was determined via a priori power analysis using G*Power 3.1.9.4. Based on the effect size (d=0.92) from Brovedani et al. (2007), a minimum of 26 infants per group is required to detect a statistically significant difference with a 5% type I error margin (α = 0.05) and 90% power (1-β = 0.90).
Attrition Allocation: To account for potential dropouts and confounding variables, the sample size was increased by 20%. Consequently, the study will include a total of 96 premature newborns, with 32 infants assigned to each of the three intervention groups.
Data Collection Tools and Forms
- Infant Information and Observation Form: Developed by the researcher based on the literature, this 11-item form records demographic and clinical data such as gestational age, birth weight, procedure duration, heart rate, oxygen saturation, and N-PASS scores.
- N-PASS Scale: A valid and reliable tool for the multidimensional assessment of pain, incorporating both physiological (heart rate, saturation, respiratory rate) and behavioral (crying, facial expression, muscle tone) components. To compensate for the limited behavioral responses of premature infants, gestational age-based points are added. The clinical goal is to maintain a score below 3.
- Physiological Measurement Tools: A monitor and a compatible pulse oximeter sensor will be placed on the infant's right hand (palmar/preductal area) to measure the average heart rate and capillary oxygen saturation before, during, and after the procedure.
- Camera: A tablet will be used to record the infant's facial expressions, behavioral responses, and monitor readings. Recording will start 3 minutes prior to the procedure and end 2 minutes after its completion.
- Heating and Puncture Devices: A radiant heater will be used to warm the nurse's hands, monitored by an infrared thermometer. A disposable mechanical/automatic lancet specifically designed for preemies (0.85 mm depth, 1.75 mm width) will be utilized for the puncture.
Study Implementation Steps
- Preparation: Following ethical committee and institutional approvals, informed written consent will be obtained from the parents. The Infant Information Form will be filled out 30 minutes before the procedure. To ensure standardization, a single researcher-nurse will perform the blood collections while another records the video.
- Positioning (15 minutes prior): The infant will be swaddled in a supine facilitated flexion position (trunk flexed, limbs in midline, head and shoulders elevated 30-45°) to provide postural support (nesting).
- Pre-procedure Intervention (2 minutes prior): 1 mL of the assigned oral solution will be slowly administered to the anterior part of the infant's tongue using a PPD syringe. Non-nutritive sucking will be initiated, and the puncture site (heel) will be warmed in the nurse's palm.
- The Procedure: The oral solution will be administered once more immediately before the puncture. The site will be cleaned with an antiseptic, punctured, and the first drop of blood wiped away before collecting the sample on Guthrie paper. An injection bandage will then be applied.
- Evaluation Process: Video recordings will be evaluated at four distinct time points: 2 minutes before (T0), during (T1), 1 minute after (T3), and 2 minutes after (T4) the procedure. The N-PASS scoring will be conducted independently by the nurse performing the procedure and an external certified neonatal nursing expert using the video footage.
Information regarding the duration of the procedure, the duration of the baby's crying, and heart rate and saturation before, during, and after the procedure will be obtained from camera recordings.
Analysis of Research Data: A statistical software package will be used to analyze the research data. The statistical significance level has been set at 0.05. Kolmogrow-Smirnov and Shapiro-Wilk tests will be used for normality analysis of dependent variables. Chi-square and mean comparison tests will be used to determine the similarity of groups. Appropriate parametric or non-parametric tests will be used to compare intra-group and between-group means, depending on whether the distribution is normal. In case of differences in between-group means, the appropriate effect size will be used according to the test family. Agreement and correlation analyses will be performed between N-PASS score evaluators. Additionally, post-hoc power analysis will be used to test whether the study was conducted with an adequate sample size. Effect Size: Cohen's d coefficient will be calculated to determine the strength of the difference between the groups.
- Conditions
- Newborn Care, Pain Management, Physiological Parameters During Newborn Care İn Newborn's, Breast Milk, Premature
- Being tested
- Administering oral breast milk in a supportive position, Administering oral 10% dextrose in a supportive position, Administering oral 20% dextrose in a supportive position
- Keywords
- premature baby, pain, breast milk, nursing care, dextrose
- Medical subject headings
- Agnosia, Premature Birth, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Administering oral breast milk in a supportive positionBehavioural
Administering oral breast milk in a supportive position
Administering oral 10% dextrose in a supportive positionBehavioural
Application of 10% dextrose solution with supportive positioning during routine heel prick blood sampling.
Administering oral 20% dextrose in a supportive positionBehavioural
Application of 20% dextrose solution with supportive positioning during routine heel prick blood sampling.
| Study group | Role | What they receive |
|---|---|---|
| breast milk group | Experimental | supportive positioning techniques during routine heel prick blood sampling and oral breastfeeding. Receives: Behavioral: Administering oral breast milk in a supportive position |
| 10% dextrose solution group | Experimental | Application of 10% dextrose solution with supportive positioning during routine heel prick blood sampling. Receives: Behavioral: Administering oral 10% dextrose in a supportive position |
| 20% dextrose solution group | Experimental | Application of 20% dextrose solution with supportive positioning during routine heel prick blood sampling. Receives: Behavioral: Administering oral 20% dextrose in a supportive position |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in the mean score of neonatal pain, agitation and sedation scale
The Neonatal Pain, Agitation, and Sedation Scale has a maximum score of 10, a minimum score of 0, and no lower limit. It is generally interpreted that "the higher the score on the scale, the more pain the baby is in."
Measured: During the procedure
Secondary outcomes (2)
The effect of orally administered breast milk, 10% and 20% dextrose solutions, along with supportive positioning techniques during heel prick blood sampling in premature infants, on heart rate.
The effect of orally administered breast milk, 10% and 20% dextrose solutions, along with supportive positioning techniques during heel prick blood sampling in premature infants, on heart rate.
Measured: During the procedure
The effect of supportive positioning techniques during heel prick blood sampling in premature infants, along with orally administered breast milk, 10% and 20% dextrose solutions, on respiratory rate.
The effect of supportive positioning techniques during heel prick blood sampling in premature infants, along with orally administered breast milk, 10% and 20% dextrose solutions, on respiratory rate.
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 posted21 Jul 2026
- Study start18 Jun 2026
- Primary completion5 Nov 2026 (estimated)
- Study completion30 Nov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Newborn CareStudies of the same condition, open and under way.
- More trials run by Mersin 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
- Model description
- Randomization and Masking: Block randomization will be preferred. Twelve different combinations \[ABCBAC (1), ACBBAC (2), AACCBB (3)\] were generated, each with a block size of 6 and containing codes A, B, and C. The combinations were numbered from 1 to 12. Combination numbers (1-12), each consisting of 16 digits in a mixed order, were generated in a random order using a computer program (randomizer.org). To conceal this assignment, each premature neonate will be numbered (1-96) according to the order of admission and placed in sealed, opaque envelopes. These envelopes will be delivered to the NICU head nurse. Supportive positioning practice is the same in the intervention groups, the only difference being oral breast milk, 20% and 10% dextrose solution. Due to the nature of the study, the practitioner and evaluator researchers cannot be masked; however, the identity of the researcher responsible for data entry, analysis, and reporting will be concealed.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 96 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mersin University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ozlem Guzel Polat, Mersin University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07716813
- Sponsor's protocol ID
- MersinU-HB-OGP-04
- Status last verified
- Oct 2026
- First submitted
- 16 Jul 2026
- Last updated
- 27 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Shann F. Suckling and sugar reduce pain in babies. Lancet. 2007 Mar 3;369(9563):721-723. doi: 10.1016/S0140-6736(07)60335-3. No abstract available.
PubMed 17336631Kim SS. Prevention and management of pain in the neonatal intensive care unit. Clin Exp Pediatr. 2020 Jan;63(1):16-17. doi: 10.3345/kjp.2019.01200. Epub 2020 Jan 15. No abstract available.
PubMed 31999914Jones L, Fabrizi L, Laudiano-Dray M, Whitehead K, Meek J, Verriotis M, Fitzgerald M. Nociceptive Cortical Activity Is Dissociated from Nociceptive Behavior in Newborn Human Infants under Stress. Curr Biol. 2017 Dec 18;27(24):3846-3851.e3. doi: 10.1016/j.cub.2017.10.063. Epub 2017 Nov 30.
PubMed 29199079Maitra S, Baidya DK, Khanna P, Ray BR, Panda SS, Bajpai M. Acute perioperative pain in neonates: An evidence-based review of neurophysiology and management. Acta Anaesthesiol Taiwan. 2014 Mar;52(1):30-7. doi: 10.1016/j.aat.2014.02.004. Epub 2014 Apr 2.
PubMed 24999216Field T. Preterm newborn pain research review. Infant Behav Dev. 2017 Nov;49:141-150. doi: 10.1016/j.infbeh.2017.09.002. Epub 2017 Sep 9.
PubMed 28898671Orovec A, Disher T, Caddell K, Campbell-Yeo M. Assessment and Management of Procedural Pain During the Entire Neonatal Intensive Care Unit Hospitalization. Pain Manag Nurs. 2019 Oct;20(5):503-511. doi: 10.1016/j.pmn.2018.11.061. Epub 2019 May 15.
PubMed 31103509Guo W, Liu X, Zhou X, Wu T, Sun J. Efficacy and safety of combined nonpharmacological interventions for repeated procedural pain in preterm neonates: A systematic review of randomized controlled trials. Int J Nurs Stud. 2020 Feb;102:103471. doi: 10.1016/j.ijnurstu.2019.103471. Epub 2019 Nov 7.
PubMed 31783193McNair C, Campbell-Yeo M, Johnston C, Taddio A. Nonpharmacologic Management of Pain During Common Needle Puncture Procedures in Infants: Current Research Evidence and Practical Considerations: An Update. Clin Perinatol. 2019 Dec;46(4):709-730. doi: 10.1016/j.clp.2019.08.006. Epub 2019 Aug 26.
PubMed 31653304Bucsea O, Pillai Riddell R. Non-pharmacological pain management in the neonatal intensive care unit: Managing neonatal pain without drugs. Semin Fetal Neonatal Med. 2019 Aug;24(4):101017. doi: 10.1016/j.siny.2019.05.009. Epub 2019 Jun 5.
PubMed 31326301
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Oral Breast Milk and 20% Dextrose Solution Administered With Supportive Positioning Methods on Pain and Physiological Variables During Heel Puncture Blood Sampling in Preterm Infants: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07716813
- Acronym / sponsor ID
- MersinU-HB-OGP-04
- Conditions
- Newborn Care, Pain Management, Physiological Parameters During Newborn Care İn Newborn's, Breast Milk, Premature
- Keywords
- premature baby, pain, breast milk, nursing care, dextrose
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 96 participants (estimated)
- Lead sponsor
- Mersin UniversityUniversity, hospital or other
- Study start
- 18 Jun 2026 (actual)
- Primary completion
- 5 Nov 2026 (estimated)
- Study completion
- 30 Nov 2026 (estimated)
- First posted
- 21 Jul 2026 (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.
Pain, defined by the International Association for the Study of Pain as a subjective, sensory, and emotional experience, differs from nociception, which is merely a neural activity. Premature newborns, whose inhibitory fibers are not yet mature due to anatomical and physiological development and who have insufficient endogenous opioid release, experience painful stimuli much more intensely. The inability of this age group to verbally express pain makes the diagnosis, assessment, and management of pain entirely dependent on healthcare professionals. Pain that is not effectively managed leads to stress and loss of comfort in the short term, while in the long term it can cause permanent neurodevelopmental problems and alter the individual's pain threshold later in life.
Premature infants, especially those in Neonatal Intensive Care Units (NICUs), are exposed to invasive procedures that cause moderate to severe pain, such as heel prick tests, much more frequently than healthy term infants. In this context, pain management is a fundamental and essential nursing responsibility for the infant's neuroprotective developmental care. The literature shows that various non-pharmacological methods, such as oral sucrose, non-nutritive sucking (NNS), facilitated flexion, and wrapping, are used to alleviate pain during interventional procedures. Although more readily available in NICUs, studies on the effectiveness of oral glucose solutions are more limited compared to sucrose.
This research, designed to address this gap in the existing literature, aims to investigate the effect of "oral breast milk, 20%, and 10% dextrose solution administered with supportive positioning methods" on pain reduction during heel prick blood sampling in premature newborns. The results of this research are expected to contribute to the development of a new, easily applicable, effective, and evidence-based nursing intervention strategy for NICUs.
Detailed description
Aim: This study aims to determine the primary effect of oral breast milk, 20% dextrose, and 10% dextrose solutions-administered alongside supportive positioning methods during routine heel lancing blood sampling (within the Neonatal Screening Program)-on pain scores in premature newborns admitted to the NICUs. Secondarily, it aims to evaluate the effects of these interventions on heart rate and oxygen saturation variables.
Hypotheses: The research hypothesizes that there is a statistically significant difference between the oral breast milk, 20% dextrose, and 10% dextrose solution groups (applied with supportive positioning) regarding pain scores (H1a), heart rate (H1b), and oxygen saturation levels (H1c) during the heel lancing procedure.
Study Design: The study will be conducted using a single-center, parallel-group, randomized controlled trial design.
Study Location: The research will take place in the Neonatal Intensive Care Unit of Mersin University Hospital.
NICUs Characteristics: The unit features a traditional open-bay design comprising two wards. It provides level 4a care and has a total incubator capacity of 27.
Work Environment and Care Approach: As a tertiary referral center, the NICUs operates on two shifts (08:00-16:00 and 16:00-08:00), with a nurse-to-infant ratio ranging from 1:1 to 1:3. The unit adopts a family-centered individualized developmental care approach. The Turkish version of the Neonatal Pain, Agitation, and Sedation Scale (N-PASS) is routinely used to evaluate and record pain scores during shift changes and interventional procedures.
Study Population: The study population will consist of premature newborns admitted to the Mersin University Hospital NICU who are scheduled for routine heel prick blood sampling.
Sample Size: The sample size was determined via a priori power analysis using G*Power 3.1.9.4. Based on the effect size (d=0.92) from Brovedani et al. (2007), a minimum of 26 infants per group is required to detect a statistically significant difference with a 5% type I error margin (α = 0.05) and 90% power (1-β = 0.90).
Attrition Allocation: To account for potential dropouts and confounding variables, the sample size was increased by 20%. Consequently, the study will include a total of 96 premature newborns, with 32 infants assigned to each of the three intervention groups.
Data Collection Tools and Forms
- Infant Information and Observation Form: Developed by the researcher based on the literature, this 11-item form records demographic and clinical data such as gestational age, birth weight, procedure duration, heart rate, oxygen saturation, and N-PASS scores.
- N-PASS Scale: A valid and reliable tool for the multidimensional assessment of pain, incorporating both physiological (heart rate, saturation, respiratory rate) and behavioral (crying, facial expression, muscle tone) components. To compensate for the limited behavioral responses of premature infants, gestational age-based points are added. The clinical goal is to maintain a score below 3.
- Physiological Measurement Tools: A monitor and a compatible pulse oximeter sensor will be placed on the infant's right hand (palmar/preductal area) to measure the average heart rate and capillary oxygen saturation before, during, and after the procedure.
- Camera: A tablet will be used to record the infant's facial expressions, behavioral responses, and monitor readings. Recording will start 3 minutes prior to the procedure and end 2 minutes after its completion.
- Heating and Puncture Devices: A radiant heater will be used to warm the nurse's hands, monitored by an infrared thermometer. A disposable mechanical/automatic lancet specifically designed for preemies (0.85 mm depth, 1.75 mm width) will be utilized for the puncture.
Study Implementation Steps
- Preparation: Following ethical committee and institutional approvals, informed written consent will be obtained from the parents. The Infant Information Form will be filled out 30 minutes before the procedure. To ensure standardization, a single researcher-nurse will perform the blood collections while another records the video.
- Positioning (15 minutes prior): The infant will be swaddled in a supine facilitated flexion position (trunk flexed, limbs in midline, head and shoulders elevated 30-45°) to provide postural support (nesting).
- Pre-procedure Intervention (2 minutes prior): 1 mL of the assigned oral solution will be slowly administered to the anterior part of the infant's tongue using a PPD syringe. Non-nutritive sucking will be initiated, and the puncture site (heel) will be warmed in the nurse's palm.
- The Procedure: The oral solution will be administered once more immediately before the puncture. The site will be cleaned with an antiseptic, punctured, and the first drop of blood wiped away before collecting the sample on Guthrie paper. An injection bandage will then be applied.
- Evaluation Process: Video recordings will be evaluated at four distinct time points: 2 minutes before (T0), during (T1), 1 minute after (T3), and 2 minutes after (T4) the procedure. The N-PASS scoring will be conducted independently by the nurse performing the procedure and an external certified neonatal nursing expert using the video footage.
Information regarding the duration of the procedure, the duration of the baby's crying, and heart rate and saturation before, during, and after the procedure will be obtained from camera recordings.
Analysis of Research Data: A statistical software package will be used to analyze the research data. The statistical significance level has been set at 0.05. Kolmogrow-Smirnov and Shapiro-Wilk tests will be used for normality analysis of dependent variables. Chi-square and mean comparison tests will be used to determine the similarity of groups. Appropriate parametric or non-parametric tests will be used to compare intra-group and between-group means, depending on whether the distribution is normal. In case of differences in between-group means, the appropriate effect size will be used according to the test family. Agreement and correlation analyses will be performed between N-PASS score evaluators. Additionally, post-hoc power analysis will be used to test whether the study was conducted with an adequate sample size. Effect Size: Cohen's d coefficient will be calculated to determine the strength of the difference between the groups.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
- Model description
- Randomization and Masking: Block randomization will be preferred. Twelve different combinations [ABCBAC (1), ACBBAC (2), AACCBB (3)] were generated, each with a block size of 6 and containing codes A, B, and C. The combinations were numbered from 1 to 12. Combination numbers (1-12), each consisting of 16 digits in a mixed order, were generated in a random order using a computer program (randomizer.org). To conceal this assignment, each premature neonate will be numbered (1-96) according to the order of admission and placed in sealed, opaque envelopes. These envelopes will be delivered to the NICU head nurse. Supportive positioning practice is the same in the intervention groups, the only difference being oral breast milk, 20% and 10% dextrose solution. Due to the nature of the study, the practitioner and evaluator researchers cannot be masked; however, the identity of the researcher responsible for data entry, analysis, and reporting will be concealed.
| Arm | Type | Receives |
|---|---|---|
| breast milk group | Experimental | Behavioral: Administering oral breast milk in a supportive positionsupportive positioning techniques during routine heel prick blood sampling and oral breastfeeding. |
| 10% dextrose solution group | Experimental | Behavioral: Administering oral 10% dextrose in a supportive positionApplication of 10% dextrose solution with supportive positioning during routine heel prick blood sampling. |
| 20% dextrose solution group | Experimental | Behavioral: Administering oral 20% dextrose in a supportive positionApplication of 20% dextrose solution with supportive positioning during routine heel prick blood sampling. |
Who may qualify
- Ages
- 32 weeks to 37 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (16 listed)
- Parental consent for the baby's participation in the study
- Admission to Mersin University Hospital NICU between July 16, 2026 and December 30, 2026,
- Gestational age at birth between 33 weeks and 37 weeks,
- Postnatal age less than 7 days,
- Heel prick blood test planned within the scope of NTP,
Key exclusion criteria (16 listed)
- Parental disapproval of infant's participation in the study
- No hospitalization at Mersin University Hospital NICUs between July 16, 2026 and December 30, 2026,
- Gestational age at birth less than 33 weeks or greater than 37 weeks,
- Postnatal age greater than 7 days,
- Heel prick blood test not planned within the scope of NTP,
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 |
|---|---|---|
| Administering oral breast milk in a supportive positionAdministering oral breast milk in a supportive position | Behavioural | breast milk group |
| Administering oral 10% dextrose in a supportive positionApplication of 10% dextrose solution with supportive positioning during routine heel prick blood sampling. | Behavioural | 10% dextrose solution group |
| Administering oral 20% dextrose in a supportive positionApplication of 20% dextrose solution with supportive positioning during routine heel prick blood sampling. | Behavioural | 20% dextrose solution group |
Primary outcome
Change in the mean score of neonatal pain, agitation and sedation scale
Time frame: During the procedure
The Neonatal Pain, Agitation, and Sedation Scale has a maximum score of 10, a minimum score of 0, and no lower limit. It is generally interpreted that "the higher the score on the scale, the more pain the baby is in."
2 secondary outcomes
The effect of orally administered breast milk, 10% and 20% dextrose solutions, along with supportive positioning techniques during heel prick blood sampling in premature infants, on heart rate.
Time frame: During the procedure
The effect of supportive positioning techniques during heel prick blood sampling in premature infants, along with orally administered breast milk, 10% and 20% dextrose solutions, on respiratory rate.
Time frame: During the procedure
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Oct 2026.
- Results publication: PubMed 17336631Shann F. Suckling and sugar reduce pain in babies. Lancet. 2007 Mar 3;369(9563):721-723. doi: 10.1016/S0140-6736(07)60335-3. No abstract available.
- Results publication: PubMed 31999914Kim SS. Prevention and management of pain in the neonatal intensive care unit. Clin Exp Pediatr. 2020 Jan;63(1):16-17. doi: 10.3345/kjp.2019.01200. Epub 2020 Jan 15. No abstract available.
- Results publication: PubMed 29199079Jones L, Fabrizi L, Laudiano-Dray M, Whitehead K, Meek J, Verriotis M, Fitzgerald M. Nociceptive Cortical Activity Is Dissociated from Nociceptive Behavior in Newborn Human Infants under Stress. Curr Biol. 2017 Dec 18;27(24):3846-3851.e3. doi: 10.1016/j.cub.2017.10.063. Epub 2017 Nov 30.
- Results publication: PubMed 24999216Maitra S, Baidya DK, Khanna P, Ray BR, Panda SS, Bajpai M. Acute perioperative pain in neonates: An evidence-based review of neurophysiology and management. Acta Anaesthesiol Taiwan. 2014 Mar;52(1):30-7. doi: 10.1016/j.aat.2014.02.004. Epub 2014 Apr 2.
- Results publication: PubMed 28898671Field T. Preterm newborn pain research review. Infant Behav Dev. 2017 Nov;49:141-150. doi: 10.1016/j.infbeh.2017.09.002. Epub 2017 Sep 9.
- Results publication: PubMed 31103509Orovec A, Disher T, Caddell K, Campbell-Yeo M. Assessment and Management of Procedural Pain During the Entire Neonatal Intensive Care Unit Hospitalization. Pain Manag Nurs. 2019 Oct;20(5):503-511. doi: 10.1016/j.pmn.2018.11.061. Epub 2019 May 15.
- Results publication: PubMed 31783193Guo W, Liu X, Zhou X, Wu T, Sun J. Efficacy and safety of combined nonpharmacological interventions for repeated procedural pain in preterm neonates: A systematic review of randomized controlled trials. Int J Nurs Stud. 2020 Feb;102:103471. doi: 10.1016/j.ijnurstu.2019.103471. Epub 2019 Nov 7.
- Results publication: PubMed 31653304McNair C, Campbell-Yeo M, Johnston C, Taddio A. Nonpharmacologic Management of Pain During Common Needle Puncture Procedures in Infants: Current Research Evidence and Practical Considerations: An Update. Clin Perinatol. 2019 Dec;46(4):709-730. doi: 10.1016/j.clp.2019.08.006. Epub 2019 Aug 26.
- Results publication: PubMed 31326301Bucsea O, Pillai Riddell R. Non-pharmacological pain management in the neonatal intensive care unit: Managing neonatal pain without drugs. Semin Fetal Neonatal Med. 2019 Aug;24(4):101017. doi: 10.1016/j.siny.2019.05.009. Epub 2019 Jun 5.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Administering oral breast milk in a supportive position, Administering oral 10% dextrose in a supportive position and Administering oral 20% dextrose in a supportive position in people with Newborn Care and Pain Management, run by Mersin 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 16 inclusion and 16 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: looking for participants now, as of the sponsor's last update on 27 Oct 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in the mean score of neonatal pain, agitation and sedation scale (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 NCT07716813, which also lists 9 linked publications.
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 27 Oct 2026.