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

NCT07777432 | Completed

• 1 other identifier: UJI-NEO-TRIPLE-2021
• Study Type: interventional
• Target: 128
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

PAIN; PAIN MANAGEMENT

Keywords

Heel prick; breastfeeding; breast milk; non-pharmacological analgesia; facilitated tucking

Outcome Measures

Primary Outcomes (2)

• Total score on the Premature Infant Pain Profile (PIPP)

  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.

  During the heel prick procedure.

• Total score on the Neonatal Infant Pain Scale (NIPS)

  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.

  During the heel prick procedure.

Secondary Outcomes (3)

• Time to cessation of crying

  Up to 5 minutes after heel prick.

• Mean heart rate

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

• Mean oxygen saturation (SpO2)

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

Study Arms (2)

Triple Combination

EXPERIMENTAL

Participants receive the Triple Combination intervention during heel prick.

Procedure: Triple Combination

Breastfeeding (Tetanalgesia)

ACTIVE COMPARATOR

Participants receive the Breastfeeding (Tetanalgesia) intervention during heel prick.

Procedure: Breastfeeding (Tetanalgesia)

Interventions

Triple Combination PROCEDURE

Triple Combination intervention administered during heel prick.

Triple Combination

Breastfeeding (Tetanalgesia) PROCEDURE

Breastfeeding (Tetanalgesia) intervention administered during heel prick.

Breastfeeding (Tetanalgesia)

Eligibility Criteria

• Age: 47 Hours - 52 Hours
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Universitat Jaume I: lead

Study Sites (1)

Hospital Comarcal de Vinaròs

Vinaròs, Castellón, 12500, Spain

Location

Related Publications (1)

• Lanchares Vallés, María Silvia. Efectividad de una Triple Combinación (leche materna, succión y contención) vs. Tetanalgesia para aliviar el dolor durante la punción del talón en recién nacidos a término : un ensayo clínico aleatorizado controlado. Tesis doctoral. Universitat Jaume I; 2025.

  BACKGROUND

Related Links

• Dialnet - Tesis doctoral
• Tesis doctoral en acceso abierto
• Repositorio UJI

MeSH Terms

Conditions

Pain; Agnosia; Breast Feeding

Interventions

Lactation

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Perceptual Disorders; Neurobehavioral Manifestations; Nervous System Diseases; Feeding Behavior; Behavior

Intervention Hierarchy (Ancestors)

Reproductive Physiological Phenomena; Reproductive and Urinary Physiological Phenomena; Postpartum Period

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Outcome assessors reviewing the video recordings were blinded to group allocation.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Participants were randomized to one of two parallel groups, Triple Combination or Breastfeeding (Tetanalgesia), and remained in the assigned group for the duration of the study.

Study Record Dates

• First Submitted: July 28, 2026
• First Posted: August 20, 2026
• Study Start: January 25, 2021
• Primary Completion: March 22, 2023
• Study Completion: March 22, 2023
• Last Updated: August 20, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)