Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
90 participants
INTERVENTIONAL
2003-01-31
2015-05-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Kangaroo care
kangaroo Care was skin-to-skin, chest-to-chest placement of preterm infant wearing only a diaper placed up against mother's chest and covered in one receiving blanket folded into fourth
Kangaroo Care
skin-to-skin, chest-to-chest placement of diaper clad preterm infant up against his mother's chest and covered by a receiving blanket folded into fourths for 2-3 hours from one feeding to the next.
control
control infants remained prone in an incubator wearing only diaper
No interventions assigned to this group
Interventions
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Kangaroo Care
skin-to-skin, chest-to-chest placement of diaper clad preterm infant up against his mother's chest and covered by a receiving blanket folded into fourths for 2-3 hours from one feeding to the next.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
7 Days
37 Weeks
ALL
No
Sponsors
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Case Western Reserve University
OTHER
Responsible Party
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Susan Ludington
Walters Professor of Pediatric Nursing
Principal Investigators
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Susan Ludington
Role: PRINCIPAL_INVESTIGATOR
Case Western Reserve University Frances Payne Bolton School of Nursing
Locations
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UH hospitals
Cleveland, Ohio, United States
Countries
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References
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Perlman JM. The genesis of cognitive and behavioral deficits in premature graduates of intensive care. Minerva Pediatr. 2003 Apr;55(2):89-101.
Whitney MP, Thoman EB. Early sleep patterns of premature infants are differentially related to later developmental disabilities. J Dev Behav Pediatr. 1993 Apr;14(2):71-80.
Holditch-Davis D, Scher M, Schwartz T, Hudson-Barr D. Sleeping and waking state development in preterm infants. Early Hum Dev. 2004 Oct;80(1):43-64. doi: 10.1016/j.earlhumdev.2004.05.006.
Scher MS, Sun M, Steppe DA, Banks DL, Guthrie RD, Sclabassi RJ. Comparisons of EEG sleep state-specific spectral values between healthy full-term and preterm infants at comparable postconceptional ages. Sleep. 1994 Feb;17(1):47-51. doi: 10.1093/sleep/17.1.47.
Sesma HW, Georgieff MK. The effect of adverse intrauterine and newborn environments on cognitive development: the experiences of premature delivery and diabetes during pregnancy. Dev Psychopathol. 2003 Fall;15(4):991-1015. doi: 10.1017/s0954579403000488.
Pillai M, James D. Behavioural states in normal mature human fetuses. Arch Dis Child. 1990 Jan;65(1 Spec No):39-43. doi: 10.1136/adc.65.1_spec_no.39.
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Feldman R, Eidelman AI. Skin-to-skin contact (Kangaroo Care) accelerates autonomic and neurobehavioural maturation in preterm infants. Dev Med Child Neurol. 2003 Apr;45(4):274-81. doi: 10.1017/s0012162203000525.
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OURTH L, BROWN KB. Inadequate mothering and disturbance in the neonatal period. Child Dev. 1961 Jun;32:287-95. doi: 10.1111/j.1467-8624.1961.tb05026.x. No abstract available.
Ludington-Hoe SM, Anderson GC, Swinth JY, Thompson C, Hadeed AJ. Randomized controlled trial of kangaroo care: cardiorespiratory and thermal effects on healthy preterm infants. Neonatal Netw. 2004 May-Jun;23(3):39-48. doi: 10.1891/0730-0832.23.3.39.
Brazy JE, Goldstein RF, Oehler JM, Gustafson KE, Thompson RJ Jr. Nursery neurobiologic risk score: levels of risk and relationships with nonmedical factors. J Dev Behav Pediatr. 1993 Dec;14(6):375-80.
Ludington-Hoe SM, Johnson MW, Morgan K, Lewis T, Gutman J, Wilson PD, Scher MS. Neurophysiologic assessment of neonatal sleep organization: preliminary results of a randomized, controlled trial of skin contact with preterm infants. Pediatrics. 2006 May;117(5):e909-23. doi: 10.1542/peds.2004-1422.
Scher MS, Jones BL, Steppe DA, Cork DL, Seltman HJ, Banks DL. Functional brain maturation in neonates as measured by EEG-sleep analyses. Clin Neurophysiol. 2003 May;114(5):875-82. doi: 10.1016/s1388-2457(03)00026-9.
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Horne RS, Bandopadhayay P, Vitkovic J, Cranage SM, Adamson TM. Effects of age and sleeping position on arousal from sleep in preterm infants. Sleep. 2002 Nov 1;25(7):746-50. doi: 10.1093/sleep/25.7.746.
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Fransson AL, Karlsson H, Nilsson K. Temperature variation in newborn babies: importance of physical contact with the mother. Arch Dis Child Fetal Neonatal Ed. 2005 Nov;90(6):F500-4. doi: 10.1136/adc.2004.066589.
Schrod L, Walter J. Effect of head-up body tilt position on autonomic function and cerebral oxygenation in preterm infants. Biol Neonate. 2002;81(4):255-9. doi: 10.1159/000056756.
Tuladhar R, Harding R, Michael Adamson T, Horne RS. Comparison of postnatal development of heart rate responses to trigeminal stimulation in sleeping preterm and term infants. J Sleep Res. 2005 Mar;14(1):29-36. doi: 10.1111/j.1365-2869.2004.00434.x.
Tornhage CJ, Stuge E, Lindberg T, Serenius F. First week kangaroo care in sick very preterm infants. Acta Paediatr. 1999 Dec;88(12):1402-4. doi: 10.1080/080352599750030167.
Franco P, Seret N, Van Hees JN, Lanquart JP Jr, Groswasser J, Kahn A. Cardiac changes during sleep in sleep-deprived infants. Sleep. 2003 Nov 1;26(7):845-8. doi: 10.1093/sleep/26.7.845.
Other Identifiers
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KangarooCareEEG
Identifier Type: -
Identifier Source: org_study_id
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