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Completed

NCT Number: NCT07777432

Triple Combination vs. Breastfeeding (Tetanalgesia) for Neonatal Pain Relief

This randomized clinical trial evaluated whether a non-pharmacological Triple Combination of expressed breast milk, sucking, and facilitated tucking reduced pain during heel prick in healthy term newborns compared with Breastfeeding (Tetanalgesia). The study included healthy term newborns with a gestational age of 37 weeks or more whose parents provided informed consent in the maternity unit of Hospital Comarcal de Vinaròs, Spain. Pain and response to the procedure were assessed by comparing the two groups, and two investigators who were not involved in data collection independently reviewed the video recordings to assign pain scores.

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Key information

Conditions

Pain Agnosia Behavior Breast Feeding Feeding Behavior Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations Pain Management Pathological Conditions, Signs and Symptoms Perceptual Disorders Signs and Symptoms

Age range

47 hour–52 hour

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hospital Comarcal de Vinaròs

Vinaròs, Castellón, 12500, Spain

About this study

The study was designed as a randomized, single-blind clinical trial with two study groups. Healthy term newborns were recruited consecutively from January 2021 to March 2023 in the maternity unit of Hospital Comarcal de Vinaròs (Castellón, Spain). After informed consent was obtained from parents or legal representatives, participants were allocated by simple randomization using sealed envelopes to one of two study groups: Triple Combination or Breastfeeding (Tetanalgesia).

In the Triple Combination group, neonates were placed in a lateral flexed position with the arms and legs close to the trunk. Sucking with a pacifier or finger was started 2 minutes before the heel prick and continued until 2 minutes after the procedure. During the procedure, 1 to 2 mL of freshly expressed breast milk was administered by syringe, while facilitated tucking was maintained throughout the procedure and for 2 minutes afterward.

In the Breastfeeding (Tetanalgesia) group, neonates were breastfed during the heel prick while being held in their mothers' arms. The procedure started after approximately 2 minutes of effective sucking and ended 2 minutes after the heel prick. Pain outcomes were assessed using the Premature Infant Pain Profile (PIPP) and the Neonatal Infant Pain Scale (NIPS). Additional outcomes included heart rate and oxygen saturation at baseline (at rest), 15 seconds after heel prick, and 30 seconds after heel prick, as well as crying duration in seconds from the start of the heel prick until crying ceased, assessed up to 5 minutes after heel prick. Two independent investigators who were not involved in data collection reviewed the video recordings to assign pain scores.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Healthy term newborns with a gestational age of 37 weeks or later.
  • Breastfed newborns.
  • Newborns undergoing heel prick.
  • Written informed consent obtained from a parent or legal guardian.

Exclusion criteria

  • Formula-fed newborns.
  • Newborns admitted to the pediatric unit for any medical condition.

Treatment and study plan

Triple Combination

Procedure

Triple Combination intervention administered during heel prick.

Breastfeeding (Tetanalgesia)

Procedure

Breastfeeding (Tetanalgesia) intervention administered during heel prick.

Primary outcomes

  1. Total score on the Premature Infant Pain Profile (PIPP)

    Time frame: During the heel prick procedure.

    Total score on the Premature Infant Pain Profile (PIPP), assessed in term newborns (gestational age ≥37 weeks) during the heel prick procedure using a 15 second behavioral observation period and a 30 second physiological/facial observation period. Possible scores range from 0 to 18, with higher scores indicating worse pain.

  2. Total score on the Neonatal Infant Pain Scale (NIPS)

    Time frame: During the heel prick procedure.

    Total score on the Neonatal Infant Pain Scale (NIPS), assessed during the heel prick procedure. The scale evaluates five behavioral responses and one physiological response to procedural pain. Possible scores range from 0 to 7, with higher scores indicating worse pain.

Secondary outcomes

  1. Time to cessation of crying

    Time frame: Up to 5 minutes after heel prick.

    Time from the start of the heel prick until cessation of crying, measured in seconds.

  2. Mean heart rate

    Time frame: Baseline (at rest), 15 seconds after heel prick, and 30 seconds after heel prick.

    Mean heart rate, measured in beats per minute, recorded in term newborns (gestational age ≥ 37 weeks) at baseline (at rest), 15 seconds after heel prick, and 30 seconds after heel prick.

  3. Mean oxygen saturation (SpO2)

    Time frame: Baseline (at rest), 15 seconds after heel prick, and 30 seconds after heel prick.

    Mean oxygen saturation (SpO2), measured as percentage, recorded in term newborns (gestational age ≥37 weeks) at baseline (at rest), 15 seconds after heel prick, and 30 seconds after heel prick.

Sponsors and collaborators

Lead sponsor

Universitat Jaume I

Other

Registry information

Official study title

Effectiveness of a Triple Combination (Breast Milk, Sucking, and Facilitated Tucking) vs. Breastfeeding (Tetanalgesia) in Term Newborns: A Randomized Clinical Trial

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Aug 20, 2026
Registry last updated
Aug 20, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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