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| Tracking Information | |||||
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| First Received Date ICMJE | December 19, 2006 | ||||
| Last Updated Date | September 24, 2008 | ||||
| Start Date ICMJE | September 2006 | ||||
| Estimated Primary Completion Date | December 2008 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
Videotaped and recorded at Baseline, Lance and Recovery:Neonatal Facial Coding System - total facial score; Heart Rate [ Time Frame: Unspecified ] [ Designated as safety issue: No ] | ||||
| Original Primary Outcome Measures ICMJE |
Videotaped and recorded at Baseline, Lance and Recovery:Neonatal Facial Coding System – total facial score; Heart Rate | ||||
| Change History | Complete list of historical versions of study NCT00414258 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE |
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| Descriptive Information | |||||
| Brief Title ICMJE | The Holding Study: Feeding Analgesia in Preterm Infants | ||||
| Official Title ICMJE | The Holding Pilot Study: Feeding Analgesia in Preterm Infants | ||||
| Brief Summary | The purpose of this study is to compare the effects of mothers' skin-to-skin holding during feeding via a soother trainer with the effects of pacifier sucking on preterm infant biobehavioural responses during and immediately after a painful procedure Hypothesis:
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| Detailed Description | Research Method: In a between subjects, randomized design, 20 stable preterm infants born between 30-35 weeks gestational age will be studied. Infants will be randomized to one of two interventions which will take place during 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 holding condition, infants will be held skin-to-skin by their mothers and given breast milk using a soother trainer during the blood collection. |
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| Study Phase | |||||
| Study Type ICMJE | Interventional | ||||
| Study Design ICMJE | Treatment, Randomized, Open Label, Placebo Control, Parallel Assignment, Efficacy Study | ||||
| Condition ICMJE | Pain | ||||
| Intervention ICMJE | Procedure: breastfeeding | ||||
| Study Arms / Comparison Groups | |||||
| Publications * | |||||
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* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Recruiting | ||||
| Estimated Enrollment ICMJE | 20 | ||||
| Estimated Completion Date | December 2008 | ||||
| Estimated Primary Completion Date | December 2008 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | |||||
| Accepts Healthy Volunteers | Yes | ||||
| Contacts ICMJE |
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| Location Countries ICMJE | Canada | ||||
| Administrative Information | |||||
| NCT ID ICMJE | NCT00414258 | ||||
| Responsible Party | Dr. Liisa Holsti, University of British Columbia | ||||
| Study ID Numbers ICMJE | C06 - 0347 | ||||
| Study Sponsor ICMJE | University of British Columbia | ||||
| Collaborators ICMJE | |||||
| Investigators ICMJE |
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| Information Provided By | University of British Columbia | ||||
| Verification Date | September 2008 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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