NCT02473055

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. .

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
90

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2003

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2003

Completed
5.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2008

Completed
6.9 years until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2015

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

June 10, 2015

Completed
6 days until next milestone

First Posted

Study publicly available on registry

June 16, 2015

Completed
Last Updated

June 18, 2015

Status Verified

June 1, 2015

Enrollment Period

5.4 years

First QC Date

June 10, 2015

Last Update Submit

June 16, 2015

Conditions

Premature Birth of Newborn

Keywords

kangaroo caresleepheart raterespiratory ratepreterm infant

Outcome Measures

Primary Outcomes (1)

  • 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

    2-3 hours

Secondary Outcomes (4)

  • Heart rates during pretest

    2-3 hours of pretest

  • Respiratory rate during pretest

    2-3 hours pretest

  • Heart rates during test

    2-3 hours of test

  • Respiratory rate during test period

    2-3 hours test period

Study Arms (2)

Kangaroo care

EXPERIMENTAL

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

Other: Kangaroo Care

control

NO INTERVENTION

control infants remained prone in an incubator wearing only diaper

Interventions

Kangaroo CareOTHER

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.

Also known as: skin-to-skin contact
Kangaroo care

Eligibility Criteria

Age7 Days - 37 Weeks
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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.

You may not qualify if:

  • Infants with encephalopathy, intraventricular hemorrhage greater than grade II, white matter lucencies on cranial ultrasound, seizures, meningitis, or congenital brain malformations were excluded

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UH hospitals

Cleveland, Ohio, 44106, United States

Location

Related Publications (31)

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    PMID: 15808441BACKGROUND

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    PMID: 15060237BACKGROUND

  • Perlman JM. The genesis of cognitive and behavioral deficits in premature graduates of intensive care. Minerva Pediatr. 2003 Apr;55(2):89-101.

    PMID: 12754453BACKGROUND

  • 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.

    PMID: 7682580BACKGROUND

  • 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.

    PMID: 15363838BACKGROUND

  • 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.

    PMID: 8191202BACKGROUND

  • 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.

    PMID: 14984135BACKGROUND

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    PMID: 2306133BACKGROUND

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    PMID: 14505599BACKGROUND

  • 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.

    PMID: 12647930BACKGROUND

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    PMID: 5659088BACKGROUND

  • Spangler G, Scheubeck R. Behavioral organization in newborns and its relation to adrenocortical and cardiac activity. Child Dev. 1993 Apr;64(2):622-33.

    PMID: 8477638BACKGROUND

  • 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.

    PMID: 14597916BACKGROUND

  • 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.

    PMID: 12850509BACKGROUND

  • 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.

    PMID: 11515146BACKGROUND

  • 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.

    PMID: 13731731BACKGROUND

  • 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.

    PMID: 15182119BACKGROUND

  • 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.

    PMID: 8126229BACKGROUND

  • 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.

    PMID: 16651294BACKGROUND

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    PMID: 12738433BACKGROUND

  • 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.

    PMID: 15050216BACKGROUND

  • 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.

    PMID: 12456937BACKGROUND

  • 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.

    PMID: 11322716BACKGROUND

  • 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.

    PMID: 12405610BACKGROUND

  • White-Traut RC, Pate CM. Modulating infant state in premature infants. J Pediatr Nurs. 1987 Apr;2(2):96-101. No abstract available.

    PMID: 3550039BACKGROUND

  • 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.

    PMID: 8318812BACKGROUND

  • 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.

    PMID: 16244210BACKGROUND

  • 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.

    PMID: 12011569BACKGROUND

  • 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.

    PMID: 15743331BACKGROUND

  • 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.

    PMID: 10626530BACKGROUND

  • 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.

    PMID: 14655918BACKGROUND

MeSH Terms

Conditions

Premature Birth

Interventions

Kangaroo-Mother Care Method

Condition Hierarchy (Ancestors)

Obstetric Labor, PrematureObstetric Labor ComplicationsPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital Diseases

Intervention Hierarchy (Ancestors)

Patient PositioningPatient CareTherapeuticsInfant CareChild CareHealth ServicesHealth Care Facilities Workforce and Services

Study Officials

  • Susan Ludington

    Case Western Reserve University Frances Payne Bolton School of Nursing

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Walters Professor of Pediatric Nursing

Study Record Dates

First Submitted

June 10, 2015

First Posted

June 16, 2015

Study Start

January 1, 2003

Primary Completion

June 1, 2008

Study Completion

May 1, 2015

Last Updated

June 18, 2015

Record last verified: 2015-06

Locations

US(1)