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

Sponsor
University of Targu Mures, Romania (Other)
Overall Status
Completed
CT.gov ID
NCT02984098
Collaborator
(none)
200
Enrollment
1
Location
2
Arms
9
Duration (Months)
22.3
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
Phase 4

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 Design

Study Type:
Interventional
Actual Enrollment :
200 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Care Provider)
Primary Purpose:
Treatment
Official Title:
40% Orally Administered Dextrose Gel is More Effective Than 25% Dextrose But Not Sufficiently Reliefs Acute Pain in Term Neonates: A Randomized Controlled Trial
Study Start Date :
Sep 1, 2014
Actual Primary Completion Date :
Jun 1, 2015
Actual Study Completion Date :
Jun 1, 2015

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

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

Secondary Outcome Measures

  1. 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. [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: First glucose level measurement was performed during heel stick by means of the last drop of collected blood Second glucose level measurement was performed 30 minutes after the heel stick.

Eligibility Criteria

Criteria

Ages Eligible for Study:
3 Days to 5 Days
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Department of Pediatrics, University of Medicine and Pharmacy Tirgu Mures Tirgu Mures Romania

Sponsors and Collaborators

  • University of Targu Mures, Romania

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

Responsible Party:
University of Targu Mures, Romania
ClinicalTrials.gov Identifier:
NCT02984098
Other Study ID Numbers:
  • POSDRU/159.5/S/133377
First Posted:
Dec 6, 2016
Last Update Posted:
Dec 6, 2016
Last Verified:
Nov 1, 2016
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Keywords provided by University of Targu Mures, Romania
procedural pain, 40% Dextrose, heel lance
Additional relevant MeSH terms:
Acute Pain

Study Results

No Results Posted as of Dec 6, 2016