| September 11, 2005 |
| July 14, 2008 |
| January 2008 |
| December 2009 (final data collection date for primary outcome measure) |
- Videotaped and recorded at Baseline, Lance and Recovery: [ Time Frame: Unspecified ] [ Designated as safety issue: No ]
- Behavioral Indicators of Infant Pain (BIIP) - total score [ Time Frame: Unspecified ] [ Designated as safety issue: No ]
- Heart Rate [ Time Frame: Unspecified ] [ Designated as safety issue: No ]
|
- Videotaped and recorded at Baseline, Lance and Recovery:
- 1. Neonatal Facial Coding System – total facial score
- 2. Heart Rate
|
| Complete list of historical versions of study NCT00175409 on ClinicalTrials.gov Archive Site |
- Videotaped and Recorded at Baseline, Lance and Recovery: [ Time Frame: Unspecified ] [ Designated as safety issue: No ]
- Hand Movements [ Time Frame: Unspecified ] [ Designated as safety issue: No ]
- Sleep/Wake States [ Time Frame: Unspecified ] [ Designated as safety issue: No ]
- Samples taken at baseline, lance and recovery [ Time Frame: Unspecified ] [ Designated as safety issue: No ]
- Salivary Cortisol sample [ Time Frame: Unspecified ] [ Designated as safety issue: No ]
- Recorded before the breast feeding intervention and at 24 hours following: [ Time Frame: Unspecified ] [ Designated as safety issue: No ]
- Preterm Infant Breastfeeding Behavior Scale [ Time Frame: Unspecified ] [ Designated as safety issue: No ]
|
- Videotaped and Recorded at Baseline, Lance and Recovery:
- 1. Hand Movements
- 2. Sleep/Wake States
- 3. Oxygen Saturation
- Samples taken at baseline and recovery:
- 1. Salivary Cortisol sample
- Recorded before the breast feeding intervention and at 24 hours following:
- 1. Preterm Infant Breastfeeding Behavior Scale
|
| |
| Breast Feeding Analgesia in Preterm Infants |
| Breast Feeding Analgesia in Preterm Infants |
The purpose of this study is to compare the effects of mothers' breastfeeding with the effects of pacifier sucking on preterm infant biobehavioural responses during and immediately after a painful procedure
Hypothesis:
- When breast fed by their mothers during blood collection, preterm infants will show less pain reaction than when sucking on a pacifier.
- Following breast feeding during the blood collection, mothers will find no differences in their infants' breast feeding ability.
|
Research Method:
In a within subjects, randomized, cross-over design, 50 stable preterm infants born between 30-36 weeks gestational age will be studied. Infants will be randomized to two interventions which will take place during two separate blood collections that are required for clinical management. For the standard care condition, infants will remain in their isolettes and will be positioned in prone and given a pacifier to suck on throughout the blood collection. For the feeding condition, infants will be held and then breast fed by their mother during the blood collection. |
| Phase I |
| Interventional |
| Prevention, Randomized, Open Label, Uncontrolled, Parallel Assignment, Efficacy Study |
| Pain |
| Procedure: Blood collection |
- Active Comparator: Infants will be randomized to two interventions which will take place during two separate blood collections that are required for clinical management. For the standard care condition, infants will remain in their isolettes and will be positioned in prone and given a pacifier to suck on throughout the blood collection.
- Active Comparator: Infants will be randomized to two interventions which will take place during two separate blood collections that are required for clinical management. For the feeding condition, infants will be held and then breast fed by their mother during the blood collection.
|
| |
| |
| Recruiting |
| 50 |
| December 2009 |
| December 2009 (final data collection date for primary outcome measure) |
Inclusion Criteria:
- born between 30-36 weeks gestational age
- breastfeeding
- mother has fluent English
Exclusion Criteria:
- CNS injury
- congenital anomaly
- active infection
- has had surgeries or analgesics/sedatives in last 72 hours
- history of maternal drug exposure
|
| Both |
| up to 37 Weeks |
| Yes |
|
|
| Canada |
| |
| NCT00175409 |
| Dr. Liisa Holsti, University of British Columbia |
| C05-0248 |
| University of British Columbia |
| SickKids Foundation |
| Principal Investigator: |
Liisa Holsti, PhD, OT |
University of British Columbia |
|
|
| University of British Columbia |
| July 2008 |