Clinical trial NCT00917631: Co-Bedding as a Comfort Measure for Twins Undergoing Painful Procedures
Official title: Co-Bedding as a Comfort Measure for Twins Undergoing Painful Procedures
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Neonatal Procedural Pain Response
Keywords: Co-bedding
Procedural pain
Twin
Comfort
RCT
Lead sponsor: IWK Health Centre
Sponsor class: OTHER
First posted: 2009-06-10
Enrollment: 134
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: A rising number of preterm twins, at high risk of undergoing repeated medical procedures often without adequate pain relief, are being admitted to Neonatal Intensive Care Units. Skin-to-skin contact between mothers and their infants during painful procedures has been shown to decrease pain and help them stabilize more quickly afterwards. The main question of this study is whether the contact of a twin could provide a similar form of comfort. Sixty-four twin pairs will have an equal chance of undergoing a medically necessary heel stick while being cared for together (co-bedding) or separately. Primary outcome will be physiologic and behavioral pain response. If found to be beneficial, changes to neonatal care practices to include co-bedding may help twins tolerate and recover from painful procedures. Findings will help care providers make recommendations for at risk twins experiencing procedural pain and add to existing theoretical models with respect to the exact mechanism of comfort through touch.


Eligibility criteria: Inclusion Criteria:

* All medically stable twin infants admitted to the NICU who are:

  1. Free from infection; and
  2. Breathing room air or receiving oxygen via nasal prongs.
* Twins may be receiving feeds via gavage tubes, IV therapy via peripheral or central line, and may be experiencing periods of apnea.

Exclusion Criteria:

* Weigh less than 1000 grams;
* Receiving ventilator support;
* Have chest tubes or umbilical catheter in situ;
* Have major congenital anomalies or chromosomal aberrations; OR
* If only one of the twins require overhead phototherapy.

Primary outcomes:
measure: Pain response(Premature Infant Pain Profile (PIPP)
timeFrame: Baseline until completion of heelstick
Secondary outcomes:
measure: Recovery
timeFrame: The length of time for heart rate and oxygen saturation to return to normal (baseline).
measure: Vagal tone
timeFrame: Baseline until completion of heelstick
measure: Hormonal stress response (Cortisol)
timeFrame: Baseline and 20 minutes post heelstick
measure: Frequency of 24% sucrose administration
timeFrame: Baseline to completion of the heelstick
measure: The response of the co-twin not receiving the painful procedure
timeFrame: Baseline to completion of the heelstick
Other outcomes:
Locations:
city: Halifax
country: Canada
facility: IWK Health Centre
state: Nova Scotia
Study officials:
affiliation: IWK Health Centre
name: Marsha L Campbell-Yeo, MN NNP-BC PhDc
role: PRINCIPAL_INVESTIGATOR
References:
citation: Campbell-Yeo ML, Johnston CC, Joseph KS, Feeley N, Chambers CT, Barrington KJ, Walker CD. Co-bedding between preterm twins attenuates stress response after heel lance: results of a randomized trial. Clin J Pain. 2014 Jul;30(7):598-604. doi: 10.1097/AJP.0000000000000015.
citation: Campbell-Yeo ML, Johnston CC, Joseph KS, Feeley N, Chambers CT, Barrington KJ. Cobedding and recovery time after heel lance in preterm twins: results of a randomized trial. Pediatrics. 2012 Sep;130(3):500-6. doi: 10.1542/peds.2012-0010. Epub 2012 Aug 27.
citation: Campbell-Yeo ML, Johnston CC, Joseph K, Feeley NL, Chambers CT, Barrington KJ. Co-bedding as a Comfort measure For Twins undergoing painful procedures (CComForT Trial). BMC Pediatr. 2009 Dec 11;9:76. doi: 10.1186/1471-2431-9-76.