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Premature Birth of NewbornNCT02473055

Kangaroo Care and Premature Infant Sleep

A study testing Kangaroo Care in people with Premature Birth of Newborn, run by Case Western Reserve University at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 7 days to 37 weeks
Conditions the study is for
Premature Birth of Newborn
What is being tested?
Kangaroo Care
Could I receive a placebo?
No, everyone receives an active treatment
How many people
90 participants
Where
1 siteUnited States
Study dates
Jan 2003to May 2015
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 7 days to 37 weeks
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

  • 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.

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

United States1 site

  • UH hospitals

    Cleveland, Ohio, 44106

Other trials in United States

About this study

Official title: A Randomized Controlled Trial of Kangaroo Care (Skin-to-Skin) Effects on Sleep in Premature Infants

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. .

Read the 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.

Being tested
Kangaroo Care
Keywords
kangaroo care, sleep, heart rate, respiratory rate, preterm infant
Medical subject headings
Premature Birth

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Kangaroo CareOther

    Also called skin-to-skin contact

    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.

Study groups in NCT02473055
Study groupRoleWhat they receive
Kangaroo careExperimentalkangaroo 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
Receives: Other: Kangaroo Care
controlNo interventioncontrol infants remained prone in an incubator wearing only diaper

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: 2-3 hours

Secondary outcomes (4)

  1. Heart rates during pretest

    Heart Rate was detected by Nihon Koden polysomnograph

    Measured: 2-3 hours of pretest

  2. Respiratory rate during pretest

    Impedance plethysmography belts attached to Nihon Koden polysomnograph machine

    Measured: 2-3 hours pretest

  3. Heart rates during test

    Heart rate was detected by Nihon Koden polysomnograph

    Measured: 2-3 hours of test

  4. Respiratory rate during test period

    Impedance plethysmography belts attached to Nihon Koden polysomnograph machine

    Measured: 2-3 hours test period

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Jun 2015 (estimated)
  2. Study startJan 2003
  3. Primary completionJun 2008
  4. Study completionMay 2015

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
90 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02473055
Sponsor's protocol ID
KangarooCareEEG
Status last verified
Jun 2015
First submitted
10 Jun 2015
Last updated
18 Jun 2015
Results posted
No
Data monitoring committee
Yes

Publications

  • 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.

    PubMed 15808441

  • 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.

    PubMed 15060237

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

    PubMed 12754453

  • 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.

    PubMed 7682580

  • 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.

    PubMed 15363838

  • 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.

    PubMed 8191202

  • 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.

    PubMed 14984135

  • 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.

    PubMed 2306133

  • 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.

    PubMed 14505599

  • 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.

    PubMed 12647930

  • 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.

    PubMed 5659088

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

    PubMed 8477638

  • 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.

    PubMed 14597916

  • 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.

    PubMed 12850509

  • 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.

    PubMed 11515146

Questions about this trial

What is this clinical trial studying?

A study testing Kangaroo Care in people with Premature Birth of Newborn, run by Case Western Reserve University at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 18 Jun 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

EEG-based sleep (time frame: 2-3 hours). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02473055, which also lists 31 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jun 2015.

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