NCT01931020

Brief Summary

RESEARCH HYPOTHESIS-In preterm neonates during heel lance oral 25% glucose is more efficacious in reducing pain as compared to oral 24% sucrose when assessed by PIPP(Premature infant pain profile)

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
94

participants targeted

Target at P50-P75 for not_applicable pain

Timeline
Completed

Started Jul 2013

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2013

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

August 21, 2013

Completed
8 days until next milestone

First Posted

Study publicly available on registry

August 29, 2013

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2014

Completed
Last Updated

June 27, 2016

Status Verified

June 1, 2016

Enrollment Period

1 year

First QC Date

August 21, 2013

Last Update Submit

June 24, 2016

Conditions

Pain

Keywords

PainPretermNeonates24% Sucrose25% Dextrose

Outcome Measures

Primary Outcomes (1)

  • Painful response

    Premature Infant Pain Profile(PIPP)

    30 seconds after heel lance

Secondary Outcomes (1)

  • Duration of Crying

    Within 2 minutes following the procedure

Other Outcomes (1)

  • Number of Participants with Adverse Events

    Within 2 minutes following the procedure

Study Arms (2)

Sucrose

ACTIVE COMPARATOR

1ml of 24%sucrose will be administered prior to heel lance

Drug: Sucrose

Glucose

EXPERIMENTAL

1ml of 25% glucose will be administered prior to heel lance

Drug: Glucose

Interventions

SucroseDRUG

The enrolled neonates will be administered 1ml of 24% sucrose. After 2 minutes heel lancing will be performed after cleaning the heel of neonate with a sterile spirit swab, with an auto lancet. Neonate's faces and monitor screen will be filmed in real time by using two independent video cameras during the entire procedure i.e. staring 2 minutes prior to heel lance and continue 2 minutes after the procedure. The PIPP will be assessed at 30 seconds, 1 minute and 2 minute after the procedure.

Also known as: 24% Sucrose
Sucrose
GlucoseDRUG

The enrolled neonates will be administered 1ml of 25% gluose. After 2 minutes heel lancing will be performed after cleaning the heel of neonate with a sterile spirit swab, with an auto lancet. Neonate's faces and monitor screen will be filmed in real time by using two independent video cameras during the entire procedure i.e. staring 2 minutes prior to heel lance and continue 2 minutes after the procedure. The PIPP will be assessed at 30 seconds, 1 minute and 2 minute after the procedure.

Also known as: 25% Glucose
Glucose

Eligibility Criteria

Age34 Weeks - 37 Weeks
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Infants born at \<37 weeks of gestational age
  • Infants within first 48 hours of post natal life
  • Infants having clinical indication for blood sampling
  • Parental consent

You may not qualify if:

  • Infants born with perinatal asphyxia, birth trauma, cardiorespiratory instability
  • Infants with 5min APGAR score \<7
  • Infants having any syndromes, congenital anomalies or previous surgery
  • Infants born to mothers known to be receiving opiates
  • Infants administered muscle relaxants, sedatives \& analgesics
  • Infants born under general anesthesia

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Lady Hardinge Medical College

New Delhi, Delhi1, 110001, India

Location

MeSH Terms

Conditions

PainPremature Birth

Interventions

SucroseGlucose

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsObstetric Labor, PrematureObstetric Labor ComplicationsPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital Diseases

Intervention Hierarchy (Ancestors)

DisaccharidesOligosaccharidesPolysaccharidesCarbohydratesSugarsHexosesMonosaccharides

Study Officials

  • Vikram Datta, MD

    Lady Hardinge Medical College

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

August 21, 2013

First Posted

August 29, 2013

Study Start

July 1, 2013

Primary Completion

July 1, 2014

Study Completion

July 1, 2014

Last Updated

June 27, 2016

Record last verified: 2016-06

Locations

IN(1)