Co-bedding as a Comfort measure For Twins undergoing painful procedures (CComForT Trial)

Marsha L Campbell-Yeo, C Celeste Johnston, Ks Joseph, Nancy L Feeley, Christine T Chambers, Keith J Barrington, Marsha L Campbell-Yeo, C Celeste Johnston, Ks Joseph, Nancy L Feeley, Christine T Chambers, Keith J Barrington

Abstract

Background: Co-bedding, a developmental care strategy, is the practice of caring for diaper clad twins in one incubator (versus separating and caring for each infant in separate incubators), thus creating the opportunity for skin-to-skin contact and touch between the twins. In studies of mothers and their infants, maternal skin-to-skin contact has been shown to decrease procedural pain response according to both behavioral and physiological indicators in very preterm neonates. It is uncertain if this comfort is derived solely from maternal presence or from stabilization of regulatory processes from direct skin contact. The intent of this study is to compare the comfort effect of co-bedding (between twin infants who are co-bedding and those who are not) on infant pain response and physiologic stability during a tissue breaking procedure (heelstick).

Methods/design: Medically stable preterm twin infants admitted to the Neonatal Intensive Care Unit will be randomly assigned to a co-bedding group or a standard care group. Pain response will be measured by physiological and videotaped facial reaction using the Premature Infant Pain Profile scale (PIPP). Recovery from the tissue breaking procedure will be determined by the length of time for heart rate and oxygen saturation to return to baseline. Sixty four sets of twins (n = 128) will be recruited into the study. Analysis and inference will be based on the intention-to-treat principle.

Discussion: If twin contact while co-bedding is determined to have a comforting effect for painful procedures, then changes in current neonatal care practices to include co-bedding may be an inexpensive, non invasive method to help maintain physiologic stability and decrease the long term psychological impact of procedural pain in this high risk population. Knowledge obtained from this study will also add to existing theoretical models with respect to the exact mechanism of comfort through touch.

Trial registration: NCT00917631.

Figures

Figure 1
Figure 1
Allocation of participants to study groups.

References

    1. Stoelhorst GM, Rijken M, Martens SE, Brand R, den Ouden AL, Wit JM, Veen S. Leiden Follow-Up Project on Prematurity. Changes in neonatology: comparison of two cohorts of very preterm infants (gestational age <32 weeks): the Project On Preterm and Small for Gestational Age Infants 1983 and the Leiden Follow-Up Project on Prematurity 1996-1997. Pediatrics. 2005;115(2):396–405. doi: 10.1542/peds.2004-1497.
    1. Luke B, Brown MB. The effect of plurality and gestation on the prevention or postponement of infant mortality: 1989-1991 versus 1999-2001. Twin Res Hum Genet. 2007;10(3):514–520. doi: 10.1375/twin.10.3.514.
    1. Millar WJ, Wadhera S, Nimrod C. Multiple births: trends and patterns in Canada, 1974-1990. Health Report. 1992;4:223–50.
    1. Minister of Public Works and Government Services Canada. Health Canada. Canadian Perinatal Health Report. Ottawa. 2003.
    1. Public Health Agency of Canada. Canadian Perinatal Health Report. 2008.
    1. Schieve LA, Meikle SF, Ferre C, Peterson HB, Jeng G, Wilcox LS. Low and very low birth weight in infants conceived with use of assisted reproductive technology. N Engl J Med. 2002;46(10):731–737. doi: 10.1056/NEJMoa010806.
    1. Blondel B, Kaminski M. Trends in the occurrence, determinants, and consequences of multiple births. Seminars in Perinatology. 2002;26:239–49. doi: 10.1053/sper.2002.34775.
    1. Wilcox LS, Kiely JL, Melvin CL, Martin MC. Assisted reproductive technologies: estimates of their contribution to multiple births and newborn hospital days in the United States. Fertility and Sterility. 1996;5:361–6.
    1. Goldenberg RL, Culhane JF, Iams JD, Romero R. Epidemiology and causes of preterm birth. Lancet. 2008;371(9606):75–84. doi: 10.1016/S0140-6736(08)60074-4.
    1. Ladden M. The impact of preterm birth on the family and society. Part 1: Psychologic sequelae of preterm birth. Pediatr Nurs. 1990;16(5):515–518.
    1. Kogan MD, Alexander GR, Kotelchuck M, MacDorman MF, Buekens P, Martin JA, Papiernik E. Trends in twin birth outcomes and prenatal care utilization in the United States, 1981-1997. JAMA. 2000;284(3):335–341. doi: 10.1001/jama.284.3.335.
    1. Martin JA, Hamilto BE, Sutton PD, Ventura SJ, Menacker F, Kirmeyer S, Munson ML. Births: Final data for 2005. National vital statistics reports. 2007;56(6)
    1. Joseph KS, Marcoux S, Ohlsson A, Liu S, Allen AC, Kramer MS, Wen SW. Fetal and Infant Heath Study Group of the Canadian Perinatal Surveillance System. Changes in stillbirth and infant mortality associated with increases in preterm birth among twins. Pediatrics. 2001;108(5):1055–1061. doi: 10.1542/peds.108.5.1055.
    1. Minister of Public Works and Government Services Canada. Health Canada. Canadian Perinatal Health Report. 2009.
    1. Kanat-Pektas M, Kunt C, Gungor T, Mollamahmutoglu L. Perinatal and first year outcomes of spontaneous versus assisted twins: a single center experience. Arch Gynecol Obstet. 2008;278:143–147. doi: 10.1007/s00404-007-0545-8.
    1. Blondel B, Kogan MD, Alexander GR, Dattani N, Kramer MS, Macfarlane A, Wen SW. The impact of the increasing number of multiple births on the rates of preterm birth and low birthweight: an international study. Am J Public Health. 2002;92(8):1323–1330. doi: 10.2105/AJPH.92.8.1323.
    1. Allen VM, Wilson RD, Cheung A. Genetics Committee of the Society of Obstetricians and Gynaecologists of Canada (SOGC); Reproductive Endocrinology Infertility Committee of the Society of Obstetricians and Gynaecologists of Canada (SOGC) Pregnancy outcomes after assisted reproductive technology. J Obstet Gynaecol Can. 2006;28(3):220–250.
    1. Qiu X, Lee SK, Tan K, Piedboeuf B, Canning R. for the Canadian Neonatal Network. Comparison of Singleton and Multiple-Birth Outcomes of Infants Born at or Before 32 Weeks of Gestation. Obstet Gynecol. 2008;111(2):365–371.
    1. Wen SW, Fung KF, Huang L, Demissie K, Joseph KS, Allen AC, Kramer MS. Fetal and Infant Health Group of the Canadian Perinatal Surveillance System. Fetal and neonatal mortality among twin gestations in a Canadian population: the effect of intrapair birthweight discordance. Am J Perinatol. 2005;22(5):279–286. doi: 10.1055/s-2005-870899.
    1. Ballabh P, Kumari J, AlKouatly HB, Yih M, Arevalo R, Rosenwaks Z, Krauss AN. Neonatal outcome of triplet versus twin and singleton pregnancies: a matched case control study. Eur J Obstet Gynecol Reprod Biol. 2003;107(1):28–36. doi: 10.1016/S0301-2115(02)00270-1.
    1. Als H. A synactive model of neonatal behavioral organization: framework for the assessment of neurobehavioral development in the premature infants and parents in the neonatal intensive care environment. Physical and Occupational Therapy in Pediatrics. 1986;6:3–53.
    1. Simons SH, van Dijk M, Anand KS, Roofthooft D, van Lingen RA, Tibboel D. Do we still hurt newborn babies? A prospective study of procedural pain and analgesia in neonates. Arch Pediatr Adolesc Med. 2003;157(11):1058–1064. doi: 10.1001/archpedi.157.11.1058.
    1. Barker DP, Rutter N. Exposure to invasive procedures in neonatal intensive care unit admissions. Arch Dis Child Fetal Neonatal Ed. 1995;72(1):F47–8. doi: 10.1136/fn.72.1.F47.
    1. Porter FL, Grunau RE, Anand KJ. Long-term effects of pain in infants. J Dev Behav Pediatr. 1999;20:253–262. doi: 10.1097/00004703-199908000-00007.
    1. Carbajal R, Rousset A, Danan C, Coquery S, Nolent P, Ducrocq S, Saizou C, Lapillonne A, Granier M, Durand P, Lenclen R, Coursol A, Hubert P, de Saint Blanquat L, Boelle PY, Annequin D, Cimerman P, Anand KJ, Breart G. Epidemiology and treatment of painful procedures in neonates in intensive care units. JAMA. 2008;300(1):60–70. doi: 10.1001/jama.300.1.60.
    1. Johnston C, Barrington K, Taddio A, Carbajal R, Brintnell J, Bryon J, Campbell-Yeo M, Chinnery H, Duhn L, Filion F, Gaal B, Manley J, Ranger M, Rich B, Shah V, Tremblay I, Vizram F, Ward V, Watts J, WeingartenEpiPPAIN Canada. Comfort Measures for Tissue-Damaging Procedures in Canadian NICU's: Have We Improved over the past Decade? EPIPPAIN Canada. Proceedings of the Pediatric Academic Society: Baltimore Maryland USA; 2009.
    1. Anand KJS. Pain, plasticity and premature birth: a prescription for permanent suffering? Nat Med. 2000;6:971–973. doi: 10.1038/79658.
    1. Ruda MA, Ling QD, Hohmann AG, Peng YB, Tachibana T. Altered nociceptive neuronal circuits after neonatal peripheral inflammation. Science. 2000;289:628–630. doi: 10.1126/science.289.5479.628.
    1. Grunau RE, Holsti L, Haley DW. Neonatal procedural pain exposure predicts lower cortisol and behavioral reactivity in preterm infants in the NICU. Pain. 2005;3:293–300. doi: 10.1016/j.pain.2004.10.020.
    1. Scanlon JW. Appreciating neonatal pain. Adv Pediatr. 1991;38:317–333.
    1. Stevens BJ, Johnston CC, Horton L. Multidimensional pain assessment in premature neonates: a pilot study. J Obstet Gynecol Neonatal Nurs. 1993;22(6):531–541. doi: 10.1111/j.1552-6909.1993.tb01838.x.
    1. Morelius E, Theodorsson E, Nelson N. Salivary cortisol and mood and pain profiles during skin-to-skin care for an unselected group of mothers and infants in neonatal intensive care. Pediatrics. 2005;116(5):1105–1113. doi: 10.1542/peds.2004-2440.
    1. Holsti L, Grunau RE, Whifield MF, Oberlander TF, Lindh V. Behavioral responses to pain are heightened after clustered care in preterm infants born between 30 and 32 weeks gestational age. Clin J Pain. 2006;22(9):757–764. doi: 10.1097/01.ajp.0000210921.10912.47.
    1. Fitzgerald M, Beggs S. The neurobiology of pain: developmental aspects. Neuroscientist. 2001;7(3):246–257. doi: 10.1177/107385840100700309.
    1. Hermann C, Hohmeister J, Demirakca S, Zohsel K, Flor H. Long-term alteration of pain sensitivity in school-aged children with early pain experiences. Pain. 2006;125(3):278–285. doi: 10.1016/j.pain.2006.08.026.
    1. Grunau RE, Oberlander TF, Whitfield MF, Fitzgerald C, Lee SK. Demographic and therapeutic determinants of pain reactivity in very low birth weight neonates at 32 Weeks' postconceptional Age. Pediatrics. 2001;107(1):105–112. doi: 10.1542/peds.107.1.105.
    1. Taddio A, Shah V, Gilbert-MacLeod C, Katz J. Conditioning and hyperalgesia in newborns exposed to repeated heel lances. JAMA. 2002;288(7):857–861. doi: 10.1001/jama.288.7.857.
    1. Taddio A, Katz J, Ilersich AL, Koren G. Effect of neonatal circumcision on pain response during subsequent routine vaccination. Lancet. 1997;349(9052):599–603. doi: 10.1016/S0140-6736(96)10316-0.
    1. American Academy of Pediatrics Committee on Fetus and Newborn, American Academy of Pediatrics Section on Surgery, Canadian Paediatric Society Fetus and Newborn Committee. Batton DG, Barrington KJ, Wallman C. Prevention and management of pain in the neonate: an update. Pediatrics. 2006;118(5):2231–2241. doi: 10.1542/peds.2006-2277.
    1. Carbajal R, Lenclen R, Jugie M, Paupe A, Barton BA, Anand KJ. Morphine does not provide adequate analgesia for acute procedural pain among preterm neonates. Pediatrics. 2005;115(6):1494–1500. doi: 10.1542/peds.2004-1425.
    1. Anand KJ, Hall RW, Desai N, Shephard B, Bergqvist LL, Young TE, Boyle EM, Carbajal R, Bhutani VK, Moore MB, Kronsberg SS, Barton BA. NEOPAIN Trial Investigators Group. Effects of morphine analgesia in ventilated preterm neonates: primary outcomes from the NEOPAIN randomised trial. Lancet. 2004;363(9422):1673–1682. doi: 10.1016/S0140-6736(04)16251-X.
    1. Slater R, Boyd S, Meek J, Fitzgerald M. Cortical pain responses in the infant brain. Pain. 2006;123(3):332. doi: 10.1016/j.pain.2006.05.009. author reply 332-4.
    1. Bartocci M, Bergqvist LL, Lagercrantz H, Anand KJ. Pain activates cortical areas in the preterm newborn brain. Pain. 2006;122(1-2):109–117. doi: 10.1016/j.pain.2006.01.015.
    1. Taddio A, Katz J. The effects of early pain experience in neonates on pain responses in infancy and childhood. Paediatr Drugs. 2005;7(4):245–257. doi: 10.2165/00148581-200507040-00004.
    1. Johnston C, Stevens BJ, Yang F, Horton L. Differential response to pain by very premature neonates. Pain. 1995;61:471–472. doi: 10.1016/0304-3959(94)00213-X.
    1. Rainville P. Brain mechanisms of pain affect and pain modulation. Curr Opin Neurobiol. 2002;12(2):195–204. doi: 10.1016/S0959-4388(02)00313-6.
    1. Jackson PL, Rainville P, Decety J. To what extent do we share the pain of others? Insight from the neural bases of pain empathy. Pain. 2006;125(1-2):5–9. doi: 10.1016/j.pain.2006.09.013.
    1. Stevens B, Yamada J, Ohlsson A. Sucrose for analgesia in newborn infants undergoing painful procedures. Cochrane Database Syst Rev. 2004;3(3):CD001069.
    1. Cignacco E, Hamers JP, Stoffel L, van Lingen RA, Gessler P, McDougall J, Nelle M. The efficacy of non-pharmacological interventions in the management of procedural pain in preterm and term neonates. A systematic literature review. Eur J Pain. 2007;11(2):139–152. doi: 10.1016/j.ejpain.2006.02.010.
    1. Shah PS, Aliwalas LI, Shah V. Breastfeeding or breast milk for procedural pain in neonates. Cochrane Database Syst Rev. 2006;3:CD004950.
    1. Shah PS, Aliwalas L, Shah V. Breastfeeding or breastmilk to alleviate procedural pain in neonates: a systematic review. Breastfeed Med. 2007;2(2):74–82. doi: 10.1089/bfm.2006.0031.
    1. Johnston CC, Filion F, Nuyt AM. Recorded maternal voice for preterm neonates undergoing heel lance. Adv Neonatal Care. 2007;7(5):258–266.
    1. Johnston CC, Filion F, Campbell-Yeo M, Goulet C, Bell L, McNaughton K, Byron J. Enhanced kangaroo mother care for heel lance in preterm neonates: a crossover trial. J Perinatol. 2009;29(1):51–56. doi: 10.1038/jp.2008.113.
    1. Marlier L, Schaal B, Soussignan R. Bottle-fed neonates prefer an odor experienced in utero to an odor experienced postnatally in the feeding context. Dev Psychobiol. 1998;33(2):133–145. doi: 10.1002/(SICI)1098-2302(199809)33:2<133::AID-DEV4>;2-K.
    1. Schaal B, Marlier L, Soussignan R. Olfactory function in the human fetus: evidence from selective neonatal responsiveness to the odor of amniotic fluid. Behav Neurosci. 1998;112(6):1438–1449. doi: 10.1037/0735-7044.112.6.1438.
    1. Rattaz C, Goubet N, Bullinger A. The calming effect of a familiar odor on full-term newborns. J Dev Behav Pediatr. 2005;26(2):86–92. doi: 10.1097/00004703-200504000-00003.
    1. Varendi H, Christensson K, Porter RH, Winberg J. Soothing effect of amniotic fluid smell in newborn infants. Early Hum Dev. 1998;51(1):47–55. doi: 10.1016/S0378-3782(97)00082-0.
    1. Goubet N, Rattaz C, Pierrat V, Bulinger A. Olfactory experience mediates response to pain in preterm newborns. Dev Psychobiol. 2003;42(2):171–172. doi: 10.1002/dev.10085.
    1. Goubet N, Strasbaugh K, Chesney J. Familiarity breeds content? Soothing effect of a familiar odor on full-term newborns. J Dev Behav Pediatr. 2007;28(3):189–194. doi: 10.1097/dbp.0b013e31802d0b8d.
    1. Gray L, Watt L, Blass EM. Skin-to-skin contact is analgesic in healthy newborns. Ped. 2000;105:14. doi: 10.1542/peds.105.1.e14.
    1. Johnston CC, Stevens B, Pinelli J. Kangaroo care is effective in diminishing pain response in preterm neonates. Arch Pediatr Adolesc Med. 2003;157(11):1084–1085. doi: 10.1001/archpedi.157.11.1084.
    1. Ludington-Hoe SM, Hosseini R, Torowicz DL. Skin-to-skin contact (Kangaroo Care) analgesia for preterm infant heel stick. AACN Clin Issues. 2005;16(3):373–87.
    1. Castral TC, Warnock F, Leite AM, Haas VJ, Scochi CG. The effects of skin-to-skin contact during acute pain in preterm newborns. 2008. pp. 464–71.
    1. Johnston CC, Filion F, Campbell-Yeo M, Goulet C, Bell L, McNaughton K, Byron J, Aita M, Finley A, Walker D. Kangaroo mother care diminishes pain from heel lance in very preterm neonates: A crossover trial. BMC Pediatrics. 2008;8(13)
    1. Kashaninia Z, Sajedi F, Rahgozar M, Noghabi FA. The effect of Kangaroo Care on behavioral responses to pain of an intramuscular injection in neonates. J Spec Pediatr Nurs. 2008;13(4):275–80. doi: 10.1111/j.1744-6155.2008.00165.x.
    1. Kostandy RR, Ludington-Hoe SM, Cong X, Abouelfettoh A, Bronson C, Stankus A, Jarrell JR. Kangaroo Care (skin contact) reduces crying response to pain in preterm neonates: pilot results. Pain Manag Nurs. 2008;9(2):55–65. doi: 10.1016/j.pmn.2007.11.004.
    1. Halimaa SL. Pain management in nursing procedures on premature babies. J Adv Nurs. 2003;42(6):587–597. doi: 10.1046/j.1365-2648.2003.02662.x.
    1. Nyqvist KH. Breast-feeding in preterm twins: Development of feeding behavior and milk intake during hospital stay and related caregiving practices. J Pediatr Nurs. 2002;17(4):246–256. doi: 10.1053/jpdn.2002.126716.
    1. Hayward K. Cobedding of twins: a natural extension of the socialization process? MCN Am J Matern Child Nurs. 2003;28(4):260–263. doi: 10.1097/00005721-200307000-00011.
    1. Fowler Byers J, Yovaish W, Lowman LB, Francis JD. Co-bedding versus single-bedding premature multiple-gestation infants in incubators. Journal of Obstetrical, Gynecological, and Neonatal Nursing. 2003;32(3):340–347. doi: 10.1177/0884217503253434.
    1. Grunau RE, Holsti L, Peters JW. Long-term consequences of pain in human neonates. Semin Fetal Neonatal Med. 2006;11(4):268–275. doi: 10.1016/j.siny.2006.02.007.
    1. Stevens B, Johnston C, Petryshen P, Taddio A. Premature infant pain profile: development and initial validation. Clin J Pain. 1996;12:13–22. doi: 10.1097/00002508-199603000-00004.
    1. Anand KJS, Barton BA, McIntosh N, Lagercrantz H, Pelausa E. Analgesia and sedation in preterm neonates who require ventilatory support: results from the NOPAIN trial. Arch Pediatr Adolesc Med. 1999;153:331–338.
    1. Ballantyne M, Stevens B, McAllister M, Dionne K, Jack A. Validation of the Premature Infant Pain Profile in theclinical setting. Clin J Pain. 1999;15:297–303. doi: 10.1097/00002508-199912000-00006.
    1. Schiller C, Stevens B, Sidani S, Ballantyne M, McNair C. Determining the clinical utility of two measures of neonatal pain. Pain Res Manag. 1999;4:60.
    1. Hayward K, Campbell-Yeo M, Price S, Morrison D, Whyte R, Cake H, Vine J. Co-bedding twins: how pilot study findings guided improvements in planning a larger multicenter trial. Nurs Res. 2007;56(2):137–143. doi: 10.1097/01.NNR.0000263967.24125.db.
    1. Ananth CV, Platt RW, Savitz DA. Regression models for clustered binary responses: implications of ignoring the intracluster correlation in an analysis of perinatal mortality in twin gestations. Ann Epidemiol. 2005;15(4):293–301. doi: 10.1016/j.annepidem.2004.08.007.

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