Kangaroo Care and Premature Infant Sleep
Primary Purpose
Premature Birth of Newborn
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Kangaroo Care
Sponsored by
About this trial
This is an interventional treatment trial for Premature Birth of Newborn focused on measuring kangaroo care, sleep, heart rate, respiratory rate, preterm infant
Eligibility Criteria
Inclusion Criteria:
- Subjects whose five-minute APGARS were greater than 6, gestational age was 28 or more weeks at birth, and whose testing weight was greater than 1000 grams were included.
Exclusion Criteria:
- Infants with encephalopathy, intraventricular hemorrhage greater than grade II, white matter lucencies on cranial ultrasound, seizures, meningitis, or congenital brain malformations were excluded
Sites / Locations
- UH hospitals
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Kangaroo care
control
Arm Description
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
control infants remained prone in an incubator wearing only diaper
Outcomes
Primary Outcome Measures
EEG-based sleep
Infants attached to EEG machine and Respiratory impedance plethysmography bands prior to beginning of pretest period and remainded on EEG until end of study
Secondary Outcome Measures
Heart rates during pretest
Heart Rate was detected by Nihon Koden polysomnograph
Respiratory rate during pretest
Impedance plethysmography belts attached to Nihon Koden polysomnograph machine
Heart rates during test
Heart rate was detected by Nihon Koden polysomnograph
Respiratory rate during test period
Impedance plethysmography belts attached to Nihon Koden polysomnograph machine
Full Information
NCT ID
NCT02473055
First Posted
June 10, 2015
Last Updated
June 16, 2015
Sponsor
Case Western Reserve University
1. Study Identification
Unique Protocol Identification Number
NCT02473055
Brief Title
Kangaroo Care and Premature Infant Sleep
Official Title
A Randomized Controlled Trial of Kangaroo Care (Skin-to-Skin) Effects on Sleep in Premature Infants
Study Type
Interventional
2. Study Status
Record Verification Date
June 2015
Overall Recruitment Status
Completed
Study Start Date
January 2003 (undefined)
Primary Completion Date
June 2008 (Actual)
Study Completion Date
May 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Case Western Reserve University
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
90 preterm infants were randomly assigned to kangaroo care (skin-to-=skin, chest-to-chest) group (n=50) or control (remained in incubator, prone (n=40) for a pretest period of 2- 3 hours, then fed, then KC group was placed in KC and control group remained in incubator for a 2-3 hr test period. EEG measures of sleep, HR, and RR were taken. .
Detailed Description
The neonatal intensive care unit (NICU) environment is not conducive to sleep, and infant sleep in incubators is fragmented. Sleep contributes to brain maturation so interventions to foster sleep are needed. During Kangaroo Care (KC) behavioral indicators of Quiet Sleep have been observed but, not confirmed by objective electroencephalographic (EEG) analysis.The purpose was to determine the effects of Kangaroo Care (KC) on EEG-based sleep using Nihon Koden polysomnography and cardiorespiratory patterns by comparing KC sleep to incubator sleep.. A randomized controlled study with 90 preterms (KC = 50; control = 40) in which KC infants received 2-3 hours of KC between feeds after a comparable pretest period in an incubator and control infants remained in an incubator during the 2-3 hour pretest and test periods. In the incubator infants were inclined, prone, and nested; in KC infants were inclined, prone, and chest-to-chest underneath a blanket. The medically stable preterm infants were a mean 32 weeks postmenstrual age.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Premature Birth of Newborn
Keywords
kangaroo care, sleep, heart rate, respiratory rate, preterm infant
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
90 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Kangaroo care
Arm Type
Experimental
Arm Description
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
Arm Title
control
Arm Type
No Intervention
Arm Description
control infants remained prone in an incubator wearing only diaper
Intervention Type
Other
Intervention Name(s)
Kangaroo Care
Other Intervention Name(s)
skin-to-skin contact
Intervention Description
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.
Primary Outcome Measure Information:
Title
EEG-based sleep
Description
Infants attached to EEG machine and Respiratory impedance plethysmography bands prior to beginning of pretest period and remainded on EEG until end of study
Time Frame
2-3 hours
Secondary Outcome Measure Information:
Title
Heart rates during pretest
Description
Heart Rate was detected by Nihon Koden polysomnograph
Time Frame
2-3 hours of pretest
Title
Respiratory rate during pretest
Description
Impedance plethysmography belts attached to Nihon Koden polysomnograph machine
Time Frame
2-3 hours pretest
Title
Heart rates during test
Description
Heart rate was detected by Nihon Koden polysomnograph
Time Frame
2-3 hours of test
Title
Respiratory rate during test period
Description
Impedance plethysmography belts attached to Nihon Koden polysomnograph machine
Time Frame
2-3 hours test period
10. Eligibility
Sex
All
Minimum Age & Unit of Time
7 Days
Maximum Age & Unit of Time
37 Weeks
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Subjects whose five-minute APGARS were greater than 6, gestational age was 28 or more weeks at birth, and whose testing weight was greater than 1000 grams were included.
Exclusion Criteria:
Infants with encephalopathy, intraventricular hemorrhage greater than grade II, white matter lucencies on cranial ultrasound, seizures, meningitis, or congenital brain malformations were excluded
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Susan Ludington
Organizational Affiliation
Case Western Reserve University Frances Payne Bolton School of Nursing
Official's Role
Principal Investigator
Facility Information:
Facility Name
UH hospitals
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44106
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
15808441
Citation
Mazurier E, Picaud JC. [Kangaroo mother care vs nidcap: a problem of semantics]. Arch Pediatr. 2005 Apr;12(4):471-2; author reply 473. doi: 10.1016/j.arcped.2004.12.019. No abstract available. French.
Results Reference
background
PubMed Identifier
15060237
Citation
Als H, Duffy FH, McAnulty GB, Rivkin MJ, Vajapeyam S, Mulkern RV, Warfield SK, Huppi PS, Butler SC, Conneman N, Fischer C, Eichenwald EC. Early experience alters brain function and structure. Pediatrics. 2004 Apr;113(4):846-57. doi: 10.1542/peds.113.4.846.
Results Reference
background
PubMed Identifier
12754453
Citation
Perlman JM. The genesis of cognitive and behavioral deficits in premature graduates of intensive care. Minerva Pediatr. 2003 Apr;55(2):89-101.
Results Reference
background
PubMed Identifier
7682580
Citation
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.
Results Reference
background
PubMed Identifier
15363838
Citation
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.
Results Reference
background
PubMed Identifier
8191202
Citation
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.
Results Reference
background
PubMed Identifier
14984135
Citation
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.
Results Reference
background
PubMed Identifier
2306133
Citation
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.
Results Reference
background
PubMed Identifier
14505599
Citation
Mirmiran M, Maas YG, Ariagno RL. Development of fetal and neonatal sleep and circadian rhythms. Sleep Med Rev. 2003 Aug;7(4):321-34. doi: 10.1053/smrv.2002.0243.
Results Reference
background
PubMed Identifier
12647930
Citation
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.
Results Reference
background
PubMed Identifier
5659088
Citation
Mestyan J, Jarai I, Fekete M. The total energy expdenditure and its components in premature infants maintained under different nursing and environmental conditions. Pediatr Res. 1968 May;2(3):161-71. doi: 10.1203/00006450-196805000-00002. No abstract available.
Results Reference
background
PubMed Identifier
8477638
Citation
Spangler G, Scheubeck R. Behavioral organization in newborns and its relation to adrenocortical and cardiac activity. Child Dev. 1993 Apr;64(2):622-33.
Results Reference
background
PubMed Identifier
14597916
Citation
Peirano P, Algarin C, Uauy R. Sleep-wake states and their regulatory mechanisms throughout early human development. J Pediatr. 2003 Oct;143(4 Suppl):S70-9. doi: 10.1067/s0022-3476(03)00404-9.
Results Reference
background
PubMed Identifier
12850509
Citation
Ohgi S, Arisawa K, Takahashi T, Kusumoto T, Goto Y, Akiyama T, Saito H. Neonatal behavioral assessment scale as a predictor of later developmental disabilities of low birth-weight and/or premature infants. Brain Dev. 2003 Aug;25(5):313-21. doi: 10.1016/s0387-7604(02)00233-4.
Results Reference
background
PubMed Identifier
11515146
Citation
Vertes RP, Eastman KE. The case against memory consolidation in REM sleep. Behav Brain Sci. 2000 Dec;23(6):867-76; discussion 904-1121. doi: 10.1017/s0140525x00004003.
Results Reference
background
PubMed Identifier
13731731
Citation
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.
Results Reference
background
PubMed Identifier
15182119
Citation
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.
Results Reference
background
PubMed Identifier
8126229
Citation
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.
Results Reference
background
PubMed Identifier
16651294
Citation
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.
Results Reference
background
PubMed Identifier
12738433
Citation
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.
Results Reference
background
PubMed Identifier
15050216
Citation
Lehtonen L, Martin RJ. Ontogeny of sleep and awake states in relation to breathing in preterm infants. Semin Neonatol. 2004 Jun;9(3):229-38. doi: 10.1016/j.siny.2003.09.002.
Results Reference
background
PubMed Identifier
12456937
Citation
Gerard CM, Harris KA, Thach BT. Spontaneous arousals in supine infants while swaddled and unswaddled during rapid eye movement and quiet sleep. Pediatrics. 2002 Dec;110(6):e70. doi: 10.1542/peds.110.6.e70.
Results Reference
background
PubMed Identifier
11322716
Citation
Franco P, Scaillet S, Valente F, Chabanski S, Groswasser J, Kahn A. Ambient temperature is associated with changes in infants' arousability from sleep. Sleep. 2001 May 1;24(3):325-9. doi: 10.1093/sleep/24.3.325.
Results Reference
background
PubMed Identifier
12405610
Citation
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.
Results Reference
background
PubMed Identifier
3550039
Citation
White-Traut RC, Pate CM. Modulating infant state in premature infants. J Pediatr Nurs. 1987 Apr;2(2):96-101. No abstract available.
Results Reference
background
PubMed Identifier
8318812
Citation
Lacy JB, Ohlsson A. Behavioral outcomes of environmental or care-giving hospital-based interventions for preterm infants: a critical overview. Acta Paediatr. 1993 Apr;82(4):408-15. doi: 10.1111/j.1651-2227.1993.tb12709.x. No abstract available.
Results Reference
background
PubMed Identifier
16244210
Citation
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.
Results Reference
background
PubMed Identifier
12011569
Citation
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.
Results Reference
background
PubMed Identifier
15743331
Citation
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.
Results Reference
background
PubMed Identifier
10626530
Citation
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.
Results Reference
background
PubMed Identifier
14655918
Citation
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.
Results Reference
background
Learn more about this trial
Kangaroo Care and Premature Infant Sleep
We'll reach out to this number within 24 hrs