The Effect of Breast Milk, 10% and 20% Dextrose on Pain and Physiological Variables During Heel Puncture in Infants

NCT07716813 | Not Yet Recruiting DMC

• 1 other identifier: MersinU-HB-OGP-04
• Study Type: interventional
• Target: 96
• Locations: 1 country
• Sites: 1

Brief 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. 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.

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

Outcome Measures

Primary Outcomes (1)

• 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."

  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.

  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.

  During the procedure

Study Arms (3)

breast milk group

EXPERIMENTAL

supportive positioning techniques during routine heel prick blood sampling and oral breastfeeding.

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.

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.

Behavioral: Administering oral 20% dextrose in a supportive position

Interventions

Administering oral 20% dextrose in a supportive position BEHAVIORAL

Application of 20% dextrose solution with supportive positioning during routine heel prick blood sampling.

20% dextrose solution group

Administering oral breast milk in a supportive position BEHAVIORAL

Administering oral breast milk in a supportive position

breast milk group

Administering oral 10% dextrose in a supportive position BEHAVIORAL

Application of 10% dextrose solution with supportive positioning during routine heel prick blood sampling.

10% dextrose solution group

Eligibility Criteria

• Age: 32 Weeks - 37 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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,
• 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…),

You may not qualify if:

• 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,
• 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,

Sponsors & Collaborators

• Mersin University: lead

Study Sites (1)

Mersin University

Mersin, 33343, Turkey (Türkiye)

Location

Related Publications (9)

• 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.

  PMID: 17336631 RESULT

• Kim 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.

  PMID: 31999914 RESULT

• Jones 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.

  PMID: 29199079 RESULT

• Maitra 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.

  PMID: 24999216 RESULT

• Field 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.

  PMID: 28898671 RESULT

• Orovec 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.

  PMID: 31103509 RESULT

• Guo 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.

  PMID: 31783193 RESULT

• McNair 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.

  PMID: 31653304 RESULT

• Bucsea 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.

  PMID: 31326301 RESULT

MeSH Terms

Conditions

Agnosia; Premature Birth; Pain

Interventions

Therapeutics; Glucose

Condition Hierarchy (Ancestors)

Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Intervention Hierarchy (Ancestors)

Hexoses; Monosaccharides; Sugars; Carbohydrates

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD, Nursing, Principal Investigator

Model Details: 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.

Study Record Dates

• First Submitted: July 16, 2026
• First Posted: July 21, 2026
• Study Start: July 18, 2026
• Primary Completion (Estimated): August 15, 2026
• Study Completion (Estimated): September 30, 2026
• Last Updated: July 24, 2026

Record last verified: 2026-07

Locations

TU (1)