Reduced Infant Response to a Routine Care Procedure After Glucose 25% Analgesia in Comparison to Materna RTF Stage 1 (glucose)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2012 by The Baruch Padeh Medical Center, Poriya.
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by (Responsible Party):
Shay Barak, The Baruch Padeh Medical Center, Poriya
ClinicalTrials.gov Identifier:
NCT01514253
First received: January 5, 2012
Last updated: January 20, 2012
Last verified: January 2012

January 5, 2012
January 20, 2012
February 2012
May 2012   (final data collection date for primary outcome measure)
less discomfort [ Time Frame: immediate, during examination (day 1) ] [ Designated as safety issue: No ]
the infant will experience less pain during examination
Same as current
Complete list of historical versions of study NCT01514253 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Reduced Infant Response to a Routine Care Procedure After Glucose 25% Analgesia in Comparison to Materna RTF Stage 1
Reduced Infant Response to a Routine Care Procedure After Glucose 25% Analgesia in Comparison to Materna RTF Stage 1

Glucose has analgesic and calming effects in newborns. To date, it is not known whether the beneficial effects extend to care giving procedures that are performed after painful procedures. The investigators objective is to determine the effect of glucose 25% analgesia in comparison to Materna RTF Stage 1 for procedural pain on infant pain responses during a subsequent care giving procedure.

During hospitalization, a neonate undergoes a number of necessary procedures that may be either painful or cause discomfort to the baby.

Pain experienced during the neonatal period is known to have long term effects on the baby.

The red-reflex test is a routine examination performed on a neonate after birth and once again before discharge from the hospital. The examination causes discomfort to the infant Glucose has analgesic and calming effects in newborns. To date, it is not known whether the beneficial effects extend to care giving procedures that are performed after painful procedures. The investigators objective is to determine the effect of glucose 25% analgesia in comparison to Materna RTF Stage 1 for procedural pain on infant pain responses during a subsequent care giving procedure.

Interventional
Not Provided
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double Blind (Caregiver, Investigator)
Infant, Newborn, Diseases
  • Drug: Glucose 25%
    1 ml glucose 25%, once
  • Dietary Supplement: Materna RTF Stage 1
    1ml Materna RTF Phase 1, 2-3 minutes prior red-reflex examination.
    Other Name: Materna RTF Phase 1
  • Other: Water for Injection
    1 ml Water for Injection (WFI), 2-3 minutes prior red-reflex examination
    Other Name: WFI
  • Experimental: glucose 25%
    1 ml of glucose once
    Intervention: Drug: Glucose 25%
  • Experimental: infant formula
    Materna RTF stage 1
    Intervention: Dietary Supplement: Materna RTF Stage 1
  • Placebo Comparator: Water for Injection
    1 ml Water for Injection (WFI), 2-3 minutes prior red-reflex examination
    Intervention: Other: Water for Injection
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Not yet recruiting
180
July 2012
May 2012   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Full term above 37 weeks gestation.
  • Normal birth-weight, healthy infants
  • Males and Females
  • Whose parents have signed the informed consent form

Exclusion Criteria:

  • Premature born below 37 weeks
  • Chromosomal abnormalities or congenital malformation.
  • Suffering neurological imbalance
  • Inability of oral feeding
Both
up to 16 Days
Yes
Contact: Shay Barak, MD 04-6652328 sbarak@poria.health.gov.il
Contact: Robyn Rubin, Coordinator 04-6652328 rrubin@poria.health.gov.il
Israel
 
NCT01514253
SAOR 006.CTIL
No
Shay Barak, The Baruch Padeh Medical Center, Poriya
The Baruch Padeh Medical Center, Poriya
Not Provided
Principal Investigator: Shay Barak, MD The Baruch Pade Medical Center - Poriya
Study Director: Amir Kushnir, MD The Baruch Padeh Medical Center - Poria
The Baruch Padeh Medical Center, Poriya
January 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP