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

July 16, 2026 updated by: Ozlem Guzel Polat, Mersin University

The Effect of Oral Breast Milk and 20% Dextrose Solution Administered With Supportive Positioning Methods on Pain and Physiological Variables During Heel Lancing 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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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 Neonatal Intensive Care Unit (NICU). 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.

NICU 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 NICU 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 Type

Interventional

Enrollment (Estimated)

96

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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…),
  • Absence of endocrine problems (e.g., hypoglycemia, hyperglycemia, large for gestational age, absence of a diabetic mother…),

Exclusion Criteria:

  • Parental disapproval of infant's participation in the study
  • No hospitalization at Mersin University Hospital NICU 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,
  • Having an endocrine and metabolic problem.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: breast milk group
supportive positioning techniques during routine heel prick blood sampling and oral breastfeeding.
Behavioral: Administering oral breast milk in a supportive position
Administering oral breast milk in a supportive position
Experimental: 10% dextrose solution group
Application of 10% dextrose solution with supportive positioning during routine heel prick blood sampling.
Behavioral: Administering oral 10% dextrose in a supportive position
Application of 10% dextrose solution with supportive positioning during routine heel prick blood sampling.
Experimental: 20% dextrose solution group
Application of 20% dextrose solution with supportive positioning during routine heel prick blood sampling.
Behavioral: Administering oral 20% dextrose in a supportive position
Application of 20% dextrose solution with supportive positioning during routine heel prick blood sampling.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in the mean score of neonatal pain, agitation and sedation scale
Time Frame: During the procedure
The Neonatal Pain Agitation and Sedation Scale (NPASS, Appendix 2), among the physiological components of the scale, heart rate, saturation, and respiratory rate variables are evaluated. Behavioral components include crying, irritability, facial expression, restlessness, and muscle tone.
During the procedure

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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 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.
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.
During the procedure

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mersin University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

July 18, 2026

Primary Completion (Estimated)

August 15, 2026

Study Completion (Estimated)

September 30, 2026

Study Registration Dates

First Submitted

July 16, 2026

First Submitted That Met QC Criteria

July 16, 2026

First Posted (Actual)

July 21, 2026

Study Record Updates

Last Update Posted (Actual)

July 21, 2026

Last Update Submitted That Met QC Criteria

July 16, 2026

Last Verified

July 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MersinU-HB-OGP-04

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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