Neonatal DiseaseNCT05465694
The Role of Time Interval Elimination on Pain Control of Preterm Infants by Sucrose Administration
A study testing 2-minute-time interval of per oral 24% sucrose and no time interval of per oral 24% sucrose in people with Neonatal Disease and Pain, Acute, run by Gulhane School of Medicine at 1 site in Turkey (Türkiye).
Trial summary
Purpose. It has been demonstrated clearly that sucrose solutions given before a minor painful procedure can reduce pain among newborns. But, there are no entirely accepted conclusions about the time scheduling of sucrose administration prior to heel lance. Read more about this study
- Who is it for?
- Ages 1 day to 90 daysHealthy volunteers can take part
- Conditions the study is for
- Neonatal Disease, Pain, Acute
- What is being tested?
- 2-minute-time interval of per oral 24% sucrose and no time interval of per oral 24% sucrose
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 98 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Mar 2019to 30 Mar 2022
- 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 1 day to 90 days
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Infants who are premature born ( ≥ 27 0/7 weeks of gestation)
- Infants who are at the postconceptional age from 34 0/7- 37 6/7 weeks of gestation
- Normal enterally fed with human milk or formula
- Infants whose mothers consented to study participation
Who cannot join
- Infants who were born depressed or with birth trauma
- Infants who have previous surgery
- Infants who have an intraventricular hemorrhage
- Infants who show signs of respiratory distress
- Infants who have an infection
- Infants with significant genetic disorders
Show all 9Show fewer
- Infants who were on sedatives, muscle relaxants, and antiepileptic
- Infants who were born to opioid-using mothers
- Infants whose parents were unable to provide written informed consent
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
University of Health Sciences, Gulhane Medicine Faculty, Department of Pediatrics, Division of Neonatology
Ankara, 06010
About this study
Purpose. It has been demonstrated clearly that sucrose solutions given before a minor painful procedure can reduce pain among newborns. But, there are no entirely accepted conclusions about the time scheduling of sucrose administration prior to heel lance. In a few studies, various time intervals between sucrose intake and heel lance procedure have been proposed. The aim of this study was to obtain a deeper knowledge of the underlying mechanism by investigating whether a different initiation of heel lance in terms of timing would reduce the effect of orally administered sucrose at heel lance among preterm newborns.
Methods. A randomized, double-blind trial with a validated, neonatal, pain-scoring scale in Gulhane Medical School Hospital in Ankara, Turkey between March 2019 and January 2021. The trial included 69 preterm newborns undergoing heel lance, who were assigned randomly to 1 of 2 groups, ie, group I, with the 2-minute-time interval of per oral 24% sucrose given prior to heel lance or group II, without a time interval of per oral sucrose given prior to heel lance. Pain-related behavior during blood sampling was measured with the Premature Infants Pain Profile-Revised (PIPP-R). Crying incidence, duration, and heart rate were also recorded. The aim of this study was to help to clarify the mechanism underlying the pain-reducing effect of orally administered sucrose by attempting to determine whether elimination of the time interval prior to heel lance would reduce the effect of oral sucrose among preterm newborns. Investigators hypothesized that there would be a significant difference in pain intensity without a waiting period after sucrose ingestion, measured at 30 and 60 s following heel lance using PIPP-R, and adverse events would be higher.
Read the detailed description
The sample size was calculated based on the difference in the PIPP scores of the groups. A sample size of 54 (27 for each group) achieves 80% power to detect a large effect size of 0.8 using a two-sided Mann-Whitney U test with a significance level of 0.05.
After inclusion in the study, participating infants were randomized to one of two possible interventions during a clinically-required heel lance: 1) The 2-minute-time interval of per oral 24% sucrose given prior to heel lance (Group 1) or no time interval of per oral 24% sucrose given prior to heel lance (Group 2) combined with containment in a blanket while in an infant incubator. Enrollment and randomization into the 2-minute-time interval of per oral 24% sucrose given prior to heel lance or no time interval of per oral 24% sucrose given prior to heel lance (within 10 s) interventions were carried out by a member of the research team using a computerized off-site password protected website. Intervention allocation concealment was achieved by using randomly permuted stratified randomization of gestational week and gender. The treatment allocations were inserted into identical sealed envelopes marked only with a number. Solutions of 24% sucrose were freshly prepared daily by pharmacy using 2.4 g sucrose plus 10 ml distilled water. Solutions were packaged in 1 ml sterile syringes and further packaged in opaque sealed envelopes labeled according to the randomization code. The research team including two clinicians and nurses were masked in the treatment allocation. Outcome assessor was also blinded.
- Conditions
- Neonatal Disease, Pain, Acute
- Being tested
- 2-minute-time interval of per oral 24% sucrose, no time interval of per oral 24% sucrose
- Keywords
- preterm, pain, sucrose, dopamine
- Medical subject headings
- Infant, Newborn, Diseases, Acute Pain, Premature Birth, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
2-minute-time interval of per oral 24% sucroseProcedure or surgery
Experiment began with a five-minute observation period of all outcome measures while infant was resting in an incubator. Later, attendant nurse gave 1 ml of 24% sucrose solution on neonate's tongue. In the 2-two minute-time interval prior to heel lance intervention, following two minutes of waiting period, heel lance procedure was applied to infant's foot. In no time interval of sucrose given immediately prior to heel lance intervention, attendant nurse performed heel lance procedure immediately after giving 1 ml of 24% sucrose solution sucrose on tongue. Infant's facial actions and heart rate, and oxygen saturation were recorded by using two video cameras. Recording was carried out by a nurse during whole procedure. After collecting data, researcher watched videos separately and scored them by using PIPP-R. Measurement of study outcome relied on data collection strategies: Neonatal close-up video recording of infant facial actions, pulse oximeter, observation for adverse events.
no time interval of per oral 24% sucroseProcedure or surgery
no time interval of per oral 24% sucrose
| Study group | Role | What they receive |
|---|---|---|
| 2-minute-time interval of per oral 24% sucrose | Active comparator | For infants in the 2-minute-time interval of per oral 24% sucrose was given prior to the heel lance intervention. Receives: Procedure: 2-minute-time interval of per oral 24% sucrose |
| no time interval of per oral 24% sucrose | Active comparator | In no time interval of sucrose was given immediately prior to heel lance intervention. Receives: Procedure: no time interval of per oral 24% sucrose |
What is being measured
The primary outcome is the main question the study is designed to answer.
Premature Infant Pain Profile-Revised (PIPP-R)
The PIPP-R is a seven indicator composite pain measure consisting of three behavioural (facials actions of brow bulge, eye squeeze, naso-labial furrow), two physiological (heart rate, oxygen saturation), and two contextual (gestational age, behavioural state) indicators validated for pain measurement in infants 26-44 weeks' gestation. A score of <7 is indicative of minimal pain and a score ≥ 12 is indicative of moderate to severe pain.
Measured: 30 seconds
Premature Infant Pain Profile-Revised (PIPP-R)
The PIPP-R is a seven indicator composite pain measure consisting of three behavioural (facials actions of brow bulge, eye squeeze, naso-labial furrow), two physiological (heart rate, oxygen saturation), and two contextual (gestational age, behavioural state) indicators validated for pain measurement in infants 26-44 weeks' gestation. A score of <7 is indicative of minimal pain and a score ≥ 12 is indicative of moderate to severe pain.
Measured: 60 seconds
Secondary outcomes (4)
Crying incidence
The proportion of infants who cry during the heel lance procedure
Measured: 120 seconds
Crying duration
The mean crying time in infants who cry
Measured: 120 seconds
Heart rate
The mean heart beat rate in a minute
Measured: 30 seconds
Heart rate
The mean heart beat rate in a minute
Measured: 60 seconds
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2022
- Study start1 Mar 2019
- Primary completion31 Jan 2021
- Study completion30 Mar 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neonatal DiseaseStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 98 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gulhane School of Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- Ankara University
- Responsible party
- Principal investigator, Deniz Yaprak, Gulhane School of Medicine
- Investigators
- Deniz Yaprak, MD, Study director, Saglik Bilimleri Universitesi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05465694
- Sponsor's protocol ID
- GEAH.Denizyaprak.137470
- Status last verified
- Jul 2022
- First submitted
- 13 Jul 2022
- Last updated
- 20 Jul 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: After acceptance of the trial registry, the director is going to decide to make individual participant data (IPD) available to other researchers.
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of Time Interval Elimination on Pain Control of Preterm Infants by Sucrose Administration
- ClinicalTrials.gov ID
- NCT05465694
- Acronym / sponsor ID
- GEAH.Denizyaprak.137470
- Conditions
- Neonatal Disease, Pain, Acute
- Keywords
- preterm, pain, sucrose, dopamine
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 98 participants (actual)
- Lead sponsor
- Gulhane School of MedicineUniversity, hospital or other
- Collaborators
- Ankara University
- Study start
- 1 Mar 2019 (actual)
- Primary completion
- 31 Jan 2021 (actual)
- Study completion
- 30 Mar 2022 (actual)
- First posted
- 20 Jul 2022 (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.
Purpose. It has been demonstrated clearly that sucrose solutions given before a minor painful procedure can reduce pain among newborns. But, there are no entirely accepted conclusions about the time scheduling of sucrose administration prior to heel lance. In a few studies, various time intervals between sucrose intake and heel lance procedure have been proposed. The aim of this study was to obtain a deeper knowledge of the underlying mechanism by investigating whether a different initiation of heel lance in terms of timing would reduce the effect of orally administered sucrose at heel lance among preterm newborns.
Methods. A randomized, double-blind trial with a validated, neonatal, pain-scoring scale in Gulhane Medical School Hospital in Ankara, Turkey between March 2019 and January 2021. The trial included 69 preterm newborns undergoing heel lance, who were assigned randomly to 1 of 2 groups, ie, group I, with the 2-minute-time interval of per oral 24% sucrose given prior to heel lance or group II, without a time interval of per oral sucrose given prior to heel lance. Pain-related behavior during blood sampling was measured with the Premature Infants Pain Profile-Revised (PIPP-R). Crying incidence, duration, and heart rate were also recorded. The aim of this study was to help to clarify the mechanism underlying the pain-reducing effect of orally administered sucrose by attempting to determine whether elimination of the time interval prior to heel lance would reduce the effect of oral sucrose among preterm newborns. Investigators hypothesized that there would be a significant difference in pain intensity without a waiting period after sucrose ingestion, measured at 30 and 60 s following heel lance using PIPP-R, and adverse events would be higher.
Detailed description
The sample size was calculated based on the difference in the PIPP scores of the groups. A sample size of 54 (27 for each group) achieves 80% power to detect a large effect size of 0.8 using a two-sided Mann-Whitney U test with a significance level of 0.05.
After inclusion in the study, participating infants were randomized to one of two possible interventions during a clinically-required heel lance: 1) The 2-minute-time interval of per oral 24% sucrose given prior to heel lance (Group 1) or no time interval of per oral 24% sucrose given prior to heel lance (Group 2) combined with containment in a blanket while in an infant incubator. Enrollment and randomization into the 2-minute-time interval of per oral 24% sucrose given prior to heel lance or no time interval of per oral 24% sucrose given prior to heel lance (within 10 s) interventions were carried out by a member of the research team using a computerized off-site password protected website. Intervention allocation concealment was achieved by using randomly permuted stratified randomization of gestational week and gender. The treatment allocations were inserted into identical sealed envelopes marked only with a number. Solutions of 24% sucrose were freshly prepared daily by pharmacy using 2.4 g sucrose plus 10 ml distilled water. Solutions were packaged in 1 ml sterile syringes and further packaged in opaque sealed envelopes labeled according to the randomization code. The research team including two clinicians and nurses were masked in the treatment allocation. Outcome assessor was also blinded.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 2-minute-time interval of per oral 24% sucrose | Active comparator | Procedure: 2-minute-time interval of per oral 24% sucroseFor infants in the 2-minute-time interval of per oral 24% sucrose was given prior to the heel lance intervention. |
| no time interval of per oral 24% sucrose | Active comparator | Procedure: no time interval of per oral 24% sucroseIn no time interval of sucrose was given immediately prior to heel lance intervention. |
Who may qualify
- Ages
- 1 day to 90 days
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Infants who are premature born ( ≥ 27 0/7 weeks of gestation)
- Infants who are at the postconceptional age from 34 0/7- 37 6/7 weeks of gestation
- Normal enterally fed with human milk or formula
- Infants whose mothers consented to study participation
Key exclusion criteria (9 listed)
- Infants who were born depressed or with birth trauma
- Infants who have previous surgery
- Infants who have an intraventricular hemorrhage
- Infants who show signs of respiratory distress
- Infants who have an infection
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 |
|---|---|---|
| 2-minute-time interval of per oral 24% sucroseExperiment began with a five-minute observation period of all outcome measures while infant was resting in an incubator. Later, attendant nurse gave 1 ml of 24% sucrose solution on neonate's tongue. In the 2-two minute-time interval prior to heel lance intervention, following two minutes of waiting period, heel lance procedure was applied to infant's foot. In no time interval of sucrose given immediately prior to heel lance intervention, attendant nurse performed heel lance procedure immediately after giving 1 ml of 24% sucrose solution sucrose on tongue. Infant's facial actions and heart rate, and oxygen saturation were recorded by using two video cameras. Recording was carried out by a nurse during whole procedure. After collecting data, researcher watched videos separately and scored them by using PIPP-R. Measurement of study outcome relied on data collection strategies: Neonatal close-up video recording of infant facial actions, pulse oximeter, observation for adverse events. | Procedure or surgery | 2-minute-time interval of per oral 24% sucrose |
| no time interval of per oral 24% sucroseno time interval of per oral 24% sucrose | Procedure or surgery | no time interval of per oral 24% sucrose |
Primary outcome
Premature Infant Pain Profile-Revised (PIPP-R)
Time frame: 30 seconds
The PIPP-R is a seven indicator composite pain measure consisting of three behavioural (facials actions of brow bulge, eye squeeze, naso-labial furrow), two physiological (heart rate, oxygen saturation), and two contextual (gestational age, behavioural state) indicators validated for pain measurement in infants 26-44 weeks' gestation. A score of <7 is indicative of minimal pain and a score ≥ 12 is indicative of moderate to severe pain.
Premature Infant Pain Profile-Revised (PIPP-R)
Time frame: 60 seconds
The PIPP-R is a seven indicator composite pain measure consisting of three behavioural (facials actions of brow bulge, eye squeeze, naso-labial furrow), two physiological (heart rate, oxygen saturation), and two contextual (gestational age, behavioural state) indicators validated for pain measurement in infants 26-44 weeks' gestation. A score of <7 is indicative of minimal pain and a score ≥ 12 is indicative of moderate to severe pain.
4 secondary outcomes
Crying incidence
Time frame: 120 seconds
Crying duration
Time frame: 120 seconds
Heart rate
Time frame: 30 seconds
Heart rate
Time frame: 60 seconds
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 Jul 2022.
- Individual participant dataSharing planned: No. After acceptance of the trial registry, the director is going to decide to make individual participant data (IPD) available to other researchers.
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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.
Deniz Yaprak, MD study director
Saglik Bilimleri Universitesi
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 2-minute-time interval of per oral 24% sucrose and no time interval of per oral 24% sucrose in people with Neonatal Disease and Pain, Acute, run by Gulhane School of Medicine at 1 site in Turkey (Türkiye).
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 9 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 Jul 2022. 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 Turkey (Türkiye). 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?
Premature Infant Pain Profile-Revised (PIPP-R) (time frame: 30 seconds). 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?
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 Jul 2022.