NCT03023267

Brief Summary

The current study will investigate the combination of the two modalities in a mixed-methods design, in order to provide comprehensive knowledge regarding the effects of family-centered MT during KC, on premature-infants' autonomic nervous system stability (measured by parasympathetic tone, physiological vital signs and behavioral states); Parents' anxiety levels; And parents' unique experiences of the intervention. Additionally, the study will analyze separately mothers and fathers to elucidate similar and different effects

Trial Health

87
On Track

Trial Health Score

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

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Aug 2017

Typical duration 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

First Submitted

Initial submission to the registry

January 10, 2017

Completed
8 days until next milestone

First Posted

Study publicly available on registry

January 18, 2017

Completed
7 months until next milestone

Study Start

First participant enrolled

August 28, 2017

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 10, 2019

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 20, 2019

Completed
Last Updated

February 25, 2020

Status Verified

February 1, 2020

Enrollment Period

2.1 years

First QC Date

January 10, 2017

Last Update Submit

February 23, 2020

Conditions

PreTerm BirthStress Reaction

Outcome Measures

Primary Outcomes (1)

  • parasympathetic tone

    The electrocardiogram analogue signal from a cardiorespiratory monitor fed into a computer containing the Heart Rate Variability (HRV) software (ANSR1000 system Ansar, Inc., Philadelphia, Pennsylvania , USA). The analogue electrocardiogram signal is converted to digital values reflecting cyclic changes in the RR interval. The data is transformed into a waveform across a spectrum of various frequencies. Frequencies measured in hertz (1 Hz = 1 cycle/sec). Applied to variability, The high frequency (HF) power spectrum is in the frequency range of \>0.15-1.80 Hz, which is predominately influenced by parasympathetic inputs.

    During intervention of music and\or kangaroo care which will carry on once during 32-36 weeks gestation and once at 3 months corrected age

Study Arms (2)

Interventional

EXPERIMENTAL

Applying music therapy with kangaroo care to mothers and fathers during their NICU hospitalization

Behavioral: Music therapy and Kangaroo care

Control

ACTIVE COMPARATOR

Applying only Kangaroo care to mothers and fathers during their stay in the NICU

Behavioral: Kangaroo Care alone

Interventions

Music therapy and Kangaroo careBEHAVIORAL

Mother holding baby in skin to skin position while singing

Interventional
Kangaroo Care aloneBEHAVIORAL

Mother holding baby in skin to skin position without singing

Control

Eligibility Criteria

Age4 Weeks - 18 Weeks
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Preterm infants ≤ 37 weeks' gestation
  • Clinically stable preterm
  • Hearing confirmed by distortion product oto- acoustic emissions

You may not qualify if:

  • Preterm infants treated with Central Nervous System (CNS) related medication (Luminal, Oxygen)
  • Infants with Intraventricular hemorrhage stage ≥ 3, Peri ventricular Leukomalacia
  • Parents refusal to participate

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Neonatal Intensive Care Unit

Kfar Saba, 44281, Israel

Location

Related Publications (1)

  • Yakobson D, Arnon S, Gold C, Elefant C, Litmanovitz I, Beck BD. Music Therapy for Preterm Infants and Their Parents: A Cluster-Randomized Controlled Trial Protocol. J Music Ther. 2020 May 2;57(2):219-242. doi: 10.1093/jmt/thaa002.

    PMID: 32112555DERIVED

MeSH Terms

Conditions

Premature BirthFractures, Stress

Interventions

Music Therapy

Condition Hierarchy (Ancestors)

Obstetric Labor, PrematureObstetric Labor ComplicationsPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesFractures, BoneWounds and Injuries

Intervention Hierarchy (Ancestors)

Sensory Art TherapiesComplementary TherapiesTherapeuticsRehabilitationAftercareContinuity of Patient CarePatient CarePsychotherapyBehavioral Disciplines and Activities

Study Officials

  • Rachel Grause, RD

    Meir Medical Center

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Senior Neonatologist

Study Record Dates

First Submitted

January 10, 2017

First Posted

January 18, 2017

Study Start

August 28, 2017

Primary Completion

October 10, 2019

Study Completion

December 20, 2019

Last Updated

February 25, 2020

Record last verified: 2020-02

Data Sharing

IPD Sharing
Will not share

Locations

IL(1)