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The Role of Time Interval Elimination on Pain Control of Preterm Infants by Sucrose Administration

Primary Purpose

Neonatal Disease, Pain, Acute

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
2-minute-time interval of per oral 24% sucrose
no time interval of per oral 24% sucrose
Sponsored by
Gulhane School of Medicine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Neonatal Disease focused on measuring preterm, pain, sucrose, dopamine

Eligibility Criteria

1 Day - 90 Days (Child)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
  • 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

Sites / Locations

  • University of Health Sciences, Gulhane Medicine Faculty, Department of Pediatrics, Division of Neonatology

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

2-minute-time interval of per oral 24% sucrose

no time interval of per oral 24% sucrose

Arm Description

For infants in the 2-minute-time interval of per oral 24% sucrose was given prior to the heel lance intervention.

In no time interval of sucrose was given immediately prior to heel lance intervention.

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

Crying incidence
The proportion of infants who cry during the heel lance procedure
Crying duration
The mean crying time in infants who cry
Heart rate
The mean heart beat rate in a minute
Heart rate
The mean heart beat rate in a minute

Full Information

First Posted
July 13, 2022
Last Updated
July 19, 2022
Sponsor
Gulhane School of Medicine
Collaborators
Ankara University
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1. Study Identification

Unique Protocol Identification Number
NCT05465694
Brief Title
The Role of Time Interval Elimination on Pain Control of Preterm Infants by Sucrose Administration
Official Title
The Role of Time Interval Elimination on Pain Control of Preterm Infants by Sucrose Administration
Study Type
Interventional

2. Study Status

Record Verification Date
July 2022
Overall Recruitment Status
Completed
Study Start Date
March 1, 2019 (Actual)
Primary Completion Date
January 31, 2021 (Actual)
Study Completion Date
March 30, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Gulhane School of Medicine
Collaborators
Ankara University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neonatal Disease, Pain, Acute
Keywords
preterm, pain, sucrose, dopamine

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
98 (Actual)

8. Arms, Groups, and Interventions

Arm Title
2-minute-time interval of per oral 24% sucrose
Arm Type
Active Comparator
Arm Description
For infants in the 2-minute-time interval of per oral 24% sucrose was given prior to the heel lance intervention.
Arm Title
no time interval of per oral 24% sucrose
Arm Type
Active Comparator
Arm Description
In no time interval of sucrose was given immediately prior to heel lance intervention.
Intervention Type
Procedure
Intervention Name(s)
2-minute-time interval of per oral 24% sucrose
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
no time interval of per oral 24% sucrose
Intervention Description
no time interval of per oral 24% sucrose
Primary Outcome Measure Information:
Title
Premature Infant Pain Profile-Revised (PIPP-R)
Description
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.
Time Frame
30 seconds
Title
Premature Infant Pain Profile-Revised (PIPP-R)
Description
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.
Time Frame
60 seconds
Secondary Outcome Measure Information:
Title
Crying incidence
Description
The proportion of infants who cry during the heel lance procedure
Time Frame
120 seconds
Title
Crying duration
Description
The mean crying time in infants who cry
Time Frame
120 seconds
Title
Heart rate
Description
The mean heart beat rate in a minute
Time Frame
30 seconds
Title
Heart rate
Description
The mean heart beat rate in a minute
Time Frame
60 seconds

10. Eligibility

Sex
All
Minimum Age & Unit of Time
1 Day
Maximum Age & Unit of Time
90 Days
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Deniz Yaprak, MD
Organizational Affiliation
Saglik Bilimleri Universitesi
Official's Role
Study Director
Facility Information:
Facility Name
University of Health Sciences, Gulhane Medicine Faculty, Department of Pediatrics, Division of Neonatology
City
Ankara
ZIP/Postal Code
06010
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
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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The Role of Time Interval Elimination on Pain Control of Preterm Infants by Sucrose Administration

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