The Holding Study: Feeding Analgesia in Preterm Infants | NCT00414258

Studies
The Holding Study: Feeding Analgesia in Preterm Infants

NCT00414258

Sponsor

University of British Columbia

Status

Completed

Last Update Posted

Apr 14, 2011Estimated

Enrollment

15Actual

Phase

Not Applicable

Conditions

Pain

Interventions

breastfeeding

Countries

Canada

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2011

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 2006

Primary Completion Date

Dec 2007Actual

Completion Date

Dec 2007Actual

First Submitted Date

Dec 19, 2006

First Submission Date that Met QC Criteria

Dec 20, 2006

First Posted Date

Dec 21, 2006Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 12, 2011

Last Update Posted Date

Apr 14, 2011Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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:

When held by their mothers during blood collection, preterm infants will show less pain reaction than when sucking on a pacifier.
Following holding during the blood collection, mothers will find no differences in their infants' feeding ability.

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

15Actual

Name	Type	Description	Arm Group Labels	Other Names
breastfeeding	Procedure	See detailed description.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Videotaped and recorded at Baseline, Lance and Recovery:Neonatal Facial Coding System - total facial score; Heart Rate

Secondary Outcomes

Measure	Description	Time Frame
Videotaped and Recorded at Baseline, Lance and Recovery:Hand Movements; Sleep/Wake States
Samples taken at baseline and recovery;Salivary Cortisol sample

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Born between 30-35 weeks gestational age
Mother has fluent English

Exclusion Criteria:

CNS injury
congenital anomaly
active infection
has had no surgeries or analgesics/sedatives in last 72 hours
history of maternal drug exposure

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

3 Days

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Liisa Holsti, Ph.D	University of British Columbia	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Children's and Women's Health Centre of British Columbia, Special Care Nursery		Vancouver	British Columbia	V6H 3V4	Canada

Condition Browse Module

MeSH Terms

ID	Term
D010146	Pain

Ancestor Terms

ID	Term
D009461	Neurologic Manifestations
D012816	Signs and Symptoms
D013568	Pathological Conditions, Signs and Symptoms

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D007774	Lactation

Ancestor Terms

ID	Term
D055703	Reproductive Physiological Phenomena
D012101	Reproductive and Urinary Physiological Phenomena
D049590	Postpartum Period

Browse Leaves

Not provided

Browse Branches

Not provided