PAINNCT07777432
Triple Combination vs. Breastfeeding (Tetanalgesia) for Neonatal Pain Relief
A study testing Triple Combination and Breastfeeding (Tetanalgesia) in people with PAIN and PAIN MANAGEMENT, run by Universitat Jaume I at 1 site in Spain.
Trial 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). Read more about this study
- Who is it for?
- Ages 47 to 52 hours
- Conditions the study is for
- PAIN, PAIN MANAGEMENT
- What is being tested?
- Triple Combination and Breastfeeding (Tetanalgesia)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 128 participants
- Where
- 1 siteSpain
- Study dates
- 25 Jan 2021to 22 Mar 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 47 to 52 hours
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- Formula-fed newborns.
- Newborns admitted to the pediatric unit for any medical condition.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effectiveness of a Triple Combination (Breast Milk, Sucking, and Facilitated Tucking) vs. Breastfeeding (Tetanalgesia) in Term Newborns: A Randomized Clinical Trial
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.
Read the detailed description
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.
- Conditions
- PAIN, PAIN MANAGEMENT
- Being tested
- Triple Combination, Breastfeeding (Tetanalgesia)
- Keywords
- Heel prick, breastfeeding, breast milk, non-pharmacological analgesia, facilitated tucking
- Medical subject headings
- Pain, Agnosia, Breast Feeding
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Triple CombinationProcedure or surgery
Triple Combination intervention administered during heel prick.
Breastfeeding (Tetanalgesia)Procedure or surgery
Breastfeeding (Tetanalgesia) intervention administered during heel prick.
| Study group | Role | What they receive |
|---|---|---|
| Triple Combination | Experimental | Participants receive the Triple Combination intervention during heel prick. Receives: Procedure: Triple Combination |
| Breastfeeding (Tetanalgesia) | Active comparator | Participants receive the Breastfeeding (Tetanalgesia) intervention during heel prick. Receives: Procedure: Breastfeeding (Tetanalgesia) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: During the heel prick procedure.
Secondary outcomes (3)
Time to cessation of crying
Time from the start of the heel prick until cessation of crying, measured in seconds.
Measured: Up to 5 minutes after heel prick.
Mean heart rate
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.
Measured: Baseline (at rest), 15 seconds after heel prick, and 30 seconds after heel prick.
Mean oxygen saturation (SpO2)
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.
Measured: Baseline (at rest), 15 seconds after heel prick, and 30 seconds after heel prick.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Aug 2026
- Study start25 Jan 2021
- Primary completion22 Mar 2023
- Study completion22 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for PAINStudies of the same condition, open and under way.
- 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
- 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.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 128 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitat Jaume I
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, María Silvia Lanchares Vallés, Universitat Jaume I
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07777432
- Sponsor's protocol ID
- UJI-NEO-TRIPLE-2021
- Status last verified
- Jul 2026
- First submitted
- 28 Jul 2026
- Last updated
- 20 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared because there is no plan for data sharing and participant confidentiality will be protected.
Publications
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.
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of a Triple Combination (Breast Milk, Sucking, and Facilitated Tucking) vs. Breastfeeding (Tetanalgesia) in Term Newborns: A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT07777432
- Acronym / sponsor ID
- UJI-NEO-TRIPLE-2021
- Conditions
- PAIN, PAIN MANAGEMENT
- Keywords
- Heel prick, breastfeeding, breast milk, non-pharmacological analgesia, facilitated tucking
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 128 participants (actual)
- Lead sponsor
- Universitat Jaume IUniversity, hospital or other
- Study start
- 25 Jan 2021 (actual)
- Primary completion
- 22 Mar 2023 (actual)
- Study completion
- 22 Mar 2023 (actual)
- First posted
- 20 Aug 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.
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.
Detailed description
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Triple Combination | Experimental | Procedure: Triple CombinationParticipants receive the Triple Combination intervention during heel prick. |
| Breastfeeding (Tetanalgesia) | Active comparator | Procedure: Breastfeeding (Tetanalgesia)Participants receive the Breastfeeding (Tetanalgesia) intervention during heel prick. |
Who may qualify
- Ages
- 47 to 52 hours
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (2 listed)
- Formula-fed newborns.
- Newborns admitted to the pediatric unit for any medical condition.
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 |
|---|---|---|
| Triple CombinationTriple Combination intervention administered during heel prick. | Procedure or surgery | Triple Combination |
| Breastfeeding (Tetanalgesia)Breastfeeding (Tetanalgesia) intervention administered during heel prick. | Procedure or surgery | Breastfeeding (Tetanalgesia) |
Primary outcome
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.
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.
3 secondary outcomes
Time to cessation of crying
Time frame: Up to 5 minutes after heel prick.
Mean heart rate
Time frame: Baseline (at rest), 15 seconds after heel prick, and 30 seconds after heel prick.
Mean oxygen saturation (SpO2)
Time frame: Baseline (at rest), 15 seconds after heel prick, and 30 seconds after heel prick.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Aug 2026.
- BackgroundLanchares 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.
- Dialnet - Tesis doctoralLink provided by the sponsor.
- Tesis doctoral en acceso abiertoLink provided by the sponsor.
- Repositorio UJILink provided by the sponsor.
- Individual participant dataSharing planned: No. Individual participant data will not be shared because there is no plan for data sharing and participant confidentiality will be protected.
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Triple Combination and Breastfeeding (Tetanalgesia) in people with PAIN and PAIN MANAGEMENT, run by Universitat Jaume I at 1 site in Spain.
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 4 inclusion and 2 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: finished, as of the sponsor's last update on 20 Aug 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 Spain. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total score on the Premature Infant Pain Profile (PIPP) (time frame: During the heel prick procedure.). The study lists 2 primary outcomes in all. 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 NCT07777432, which also lists 1 linked publication.
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 20 Aug 2026.