40% Orally Administered Dextrose Gel is More Effective Than 25% Dextrose (40%D-N-PP)

December 1, 2016 updated by: University of Targu Mures, Romania

40% Orally Administered Dextrose Gel is More Effective Than 25% Dextrose But Not Sufficiently Reliefs Acute Pain in Term Neonates: A Randomized Controlled Trial

The aim of this study was to evaluate the safe of 40% Dextrose oral administration on blood glucose concentration and to reducing of pain before painful procedures on healthy term neonate 72 hours aged.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

During the study period around 2000 term neonates were born in the university affiliated hospital. Five to 7 term neonates were assessed weekly by the principal investigator (PI) for study eligibility. The parents of neonates who met the inclusion criteria received information about the study after which they were invited to participate. Written informed consent from parent was obtained. The PI entered data into the online Research Randomizer which provided a randomization number corresponding to a numbered treatment pack containing two syringes, each containing 2ml of an identical and therefore blinded liquid. Study investigators, clinical staff, parents and monitors remained blinded to treatment allocation until data analysis was completed. To ensure standardization the included term infants were not breastfeed 30' prior to the heel stick and a standardized heel lance was used.Each infant was taken to a separate room with the mother by the assigned nurse to provide a quite environment. All infants were awake at the time of the procedure. Their clothes were removed and wet diapers were changed. In both groups, the infants were placed in a supine position on a changing table. Dextrose administration and the heel stick were undertaken by an experienced staff neonatal nurse. The heel was warmed with a warm wet towel up 2' minutes before the procedure. The heel was disinfected shortly before the procedure started.

Study Type

Interventional

Enrollment (Actual)

200

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Romania
      • Tirgu Mures, Romania
        • Department of Pediatrics, University of Medicine and Pharmacy Tirgu Mures

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

3 days to 5 days (CHILD)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • were born at ≥ 37 weeks of gestation were
  • APGAR score of ≥ 7 five minutes after birth
  • had a postnatal age of ≥ 72 hours
  • were breastfed (but not 30' prior to the testing HS)
  • were undergoing a routine heel stick for metabolic screening between the third and fifth postnatal day

Exclusion Criteria:

  • any kind of medical instabilities needing a transfer to the neonatal intensive care unit (NICU)
  • severe intrapartum asphyxia defined as a 5' Apgar score less than 3
  • parenteral nutrition and the presence of neurological symptoms
  • congenital anomalies
  • other conditions requiring treatment for hypo- or hyperglycemia
  • those in which the heel lance procedure failed

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Dextrose gel 40%
before heel lance, 2 ml oral dextrose gel 40% was administered, and pain related intensity was evaluated with premature infant pain profile scale
Drug: Dextrose
before heel lance, 2ml oral dextrose gel 25%or 40% was administered, and pain related intensity was evaluated with premature infant pain profile scale
ACTIVE_COMPARATOR: Dextrose gel 25%
before heel lance, 2ml oral dextrose gel 25% was administered, and pain related intensity was evaluated with premature infant pain profile scale
Drug: Dextrose
before heel lance, 2ml oral dextrose gel 25%or 40% was administered, and pain related intensity was evaluated with premature infant pain profile scale

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pain reactivity changes after orally administered 0.5 ml/ kg body 40% dextrose gel or 25% dextrose as procedural pain relief in term neonates requiring a routine heel stick 72 hours after birth.
Time Frame: one routine heel stick 72 hours after birth

Pain reactivity changes were assessed using the Premature Infant Pain Profile-revised (PIPP-R scale) which is composed of three behavioral, two physiological and two contextual pain indicators. Five measurements were undertaken during one routine heel stick which took place 72 hours after birth, on the bed side and coded through direct observation during 15 seconds at 5 different time points:

  1. t0: before the heel lance (= baseline 30 minutes without stimuli before heel stick);
  2. t1: at the end of the heel lance (after the ending of the squeezing of the heel and successful collection of blood drops);
  3. t2: at 1 minute recovery time;
  4. t3: at 2 minutes recovery time;
  5. t4: at 5' minutes recovery time.
one routine heel stick 72 hours after birth

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Blood glucose levels changes after orally administered 0.5 ml/kg body 40% dextrose gel or 25% dextrose as procedural pain relief in term neonates requiring a routine heel stick 72 hours after birth.
Time Frame: one routine heel stick 72 hours after birth and at 30 minutes after orally 0.5 ml/kg body 40% dextrose gel or 25% dextrose

Blood glucose levels were measured at two different time points:

  1. First glucose level measurement was performed during heel stick by means of the last drop of collected blood
  2. Second glucose level measurement was performed 30 minutes after the heel stick.
one routine heel stick 72 hours after birth and at 30 minutes after orally 0.5 ml/kg body 40% dextrose gel or 25% dextrose

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Targu Mures, Romania

Investigators

  • Principal Investigator: LAURA MIHAELA SUCIU, MD,PhD, University of Targu Mures, Romania

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2014

Primary Completion (ACTUAL)

June 1, 2015

Study Completion (ACTUAL)

June 1, 2015

Study Registration Dates

First Submitted

November 16, 2016

First Submitted That Met QC Criteria

December 1, 2016

First Posted (ESTIMATE)

December 6, 2016

Study Record Updates

Last Update Posted (ESTIMATE)

December 6, 2016

Last Update Submitted That Met QC Criteria

December 1, 2016

Last Verified

November 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • POSDRU/159.5/S/133377

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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