Trial document




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  DRKS00017755

Trial Description

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Title

Employment/Use of Webcams in Neonatal Intensive Care Units

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Trial Acronym

Neo-CamCare

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URL of the Trial

http://www.neocamcare.de

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Brief Summary in Lay Language

Premature babies with a critical birth weight are cared for in perinatal centres. In 2016, this applied to approx. 10,500 premature babies in Germany.
It is not always possible for mothers and fathers to be permanently present at the hospital with their child. This separation may entail major consequences for the parents and the parental-child relationship or the parental bond as a whole. For this reason, some institutions offer the possibility to watch the baby via a webcam. Until now, this service is only available in a few neonatal intensive care units (NICUs) in Germany.
At present, there is no scientifically proven evidence on the advantages and disadvantages of camera use in neonatal intensive care units in Germany.
The aim of the Neo-CamCare study is therefore to investigate camera use in neonatal intensive care units and to identify possible advantages and disadvantages. It is currently assumed that the cameras can reduce the psychological strain on parents and have positive effects on the supply of the premature baby with breast milk.
Parents whose child weighs less than 1,500 grams at birth, stays in one of the participating intensive care units and was born during the study period can participate in the study.

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Brief Summary in Scientific Language

The aim of this study is to analyse qualitatively, quantitatively, and to evaluate the employment/use of webcams in NICUs in Germany (work package (WP) 5). Simultaneously, the parents need (WP2), possible barriers to implementation, and the concerns of parents as well as physicians and nursing staff will be examined (WP1 and WP 2). Afterwards, a practical guide, which will comprise recommendations for parents and clinical staff regarding the use/employment and handling of the webcams, will be developed (WP4). Furthermore, the additional workload of the nurses will be analysed (WP3) and important issues of labour and data protection law will be clarified (WP6).
The study will follow a mixed-methods-approach and contains (a) qualitative (individual interviews, group discussions, and observations (WP1, WP2, WP4, and WP5)) and (b) quantitative (standardised postal surveys (WP1, WP2, WP5), documentation of additional workload in terms of time (WP3), and analysis of log-in-data (WP5)) forms of data collection.
The results will empower a structured, scientifically sound use/employment of webcams in NICUs in Germany and address the needs of both parents and the clinical staff involved.

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Do you plan to share individual participant data with other researchers?

Yes

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Description IPD sharing plan:

Data can be made available in anonymous form on request.

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Organizational Data

  •   DRKS00017755
  •   2019/09/25
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  •   yes
  •   Approved
  •   19-1232, Ethik-Kommission der Medizinischen Fakultät der Universität zu Köln
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Secondary IDs

  •   U1111-1237-6039 
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Health Condition or Problem studied

  •   Mental/Emotional strain in parents in case of physical separation of a preterm infant
  •   P07.01 -  [generalization P07.0: Extremely low birth weight]
  •   P07.02 -  [generalization P07.0: Extremely low birth weight]
  •   P07.10 -  [generalization P07.1: Other low birth weight]
  •   P07.11 -  [generalization P07.1: Other low birth weight]
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Interventions/Observational Groups

  •   WP1
    Survey of all medical and nursing directors of German NICUs
    Qualitative: n=4 leading physicians and n=4 leading nurses
    (In preparation of the quantitative survey instrument)
    Quantitative: n=211 NICUs
  •   WP2
    Survey of parents of premature babies via the cooperating health insurances
    Qualitative: Interviews with n=8 parental couples
    (In preparation of the quantitative survey instrument)
    Quantitative: Parents of n=2,100 premature babies
  •   WP3 Observation of the additional workload of nursing staff by means of a participant observation and diary study 300 days
  •   WP4
    Development of a practice guide
    Interviews with n=20 parents, n=10 nurses, and n=5 physicians
  •   WP5
    Randomised wait-list controlled trial: parents of preterm infants in NICUs – both groups may use the camera for one month staggered monthly (Group A first month with webcam); In the observation period of 2 months the parents take part in 4 written surveys every two weeks
    Summative outcome evaluation in the participating NICUs, parents of approx. n=730 preterm infants
  •   WP5
    Randomised wait-list controlled trial: parents of preterm infants in NICUs – both groups may use the camera for one month staggered monthly (Group B first month without webcam); In the observation period of 2 months the parents take part in 4 written surveys every two weeks
    Summative outcome evaluation in the participating NICUs, parents of approx. n=730 preterm infants
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Characteristics

  •   Interventional
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  •   Randomized controlled trial
  •   Open (masking not used)
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  •   Other
  •   Other
  •   Crossover
  •   N/A
  •   N/A
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Primary Outcome

Mental strain of parents with a very low birthweight infant (Questionnaire)
survey dates: after 2,4, 6 and 8 weeks

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Secondary Outcome

Nutrition of preterm infant with breast milk (measurement)
Parental child relationship as perceived by the parents (questionnaire)
Parental confidence in care of infant (questionnaire)
Employment of action aid (questionnaire)

Survey dates: after 2, 4, 6 and 8 weeks

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • Medical Center 
  • Medical Center 
  • Medical Center 
  • Medical Center 
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Recruitment

  •   Actual
  •   2019/10/24
  •   730
  •   Multicenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   no minimum age
  •   no maximum age
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Additional Inclusion Criteria

- Parents of a preterm infant
- Preterm infant weighs less than 1,500 grams
- Preterm infant stays in one of the participating NICUs
- Preterm infant was born during study period (expected Dec. 2019 - Sept. 2021)

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Exclusion Criteria

none defined

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Addresses

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    • Institut für Medizinsoziologie, Versorgungsforschung und Rehabilitationswissenschaft (IMVR) der Humanwissenschaftlichen Fakultät und der Medizinischen Fakultät der Universität zu Köln
    • Mr.  Prof. Dr.  Holger  Pfaff 
    • Eupener Str. 129
    • 50933  Köln
    • Germany
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    • Forschungsstelle Ethik
    • Ms.  Prof. Dr.  Christiane  Woopen 
    • Universitätsstr. 91
    • 50931  Köln
    • Germany
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    • Seminar für ABWL und MIG Universität zu Köln
    • Mr.  Prof. Dr.  Ludwig  Kuntz 
    • Dürener Str. 56-60
    • 50931  Köln
    • Germany
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    • Zentrum für Kinderheilkunde Universitätsklinikum Bonn
    • Mr.  Dr.  Till  Dresbach 
    • Adenauerallee 119
    • 53113  Bonn
    • Germany
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    • Zentrum für Kinderheilkunde Universitätsklinikum Bonn
    • Mr.  Prof. Dr.  Andreas  Müller 
    • Adenauerallee 119
    • 53113  Bonn
    • Germany
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    • Forschungsstelle Ethik/ ceres Uniklinik Köln
    • Ms.  Christiane  Jannes 
    • Universitätsstraße 91
    • 50931  Köln
    • Germany
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    • Institut für Medizinische Statistik und Bioinformatik - medizinische Fakultät - Universität zu Köln
    • Mr.  Prof. Dr.  Martin  Hellmich 
    • Robert-Koch-Str. 10
    • 50931  Köln
    • Germany
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    • Institut für Medizinische Statistik und Bioinformatik - medizinische Fakultät - Universität zu Köln
    • Christina  Samel 
    • Robert-Koch-Str. 10
    • 50931  Köln
    • Germany
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    • Goethe-Universität Frankfurt am Main
    • Ms.  Prof. Dr.  Indra  Spiecker gen. Döhmann 
    • Theodor-W.-Adorno-Platz 4
    • 60629  Frankfurt am Main
    • Germany
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    • Goethe-Universität Frankfurt am Main
    • Mr.  Dr.  Sebastian  Bretthauer 
    • Theodor-W.-Adorno-Platz 4
    • 60629  Frankfurt am Main
    • Germany
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    • DAK Gesundheit Vorstandsreferat Versorgungsforschung
    • Ms.  Stefanie  Wobbe-Ribinski 
    • Nagelsweg 27-31
    • 20097  Hamburg
    • Germany
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    • Techniker Krankenkasse Versorgungsmanagement
    • Mr.  Dr.  Dirk  Horenkamp-Sonntag 
    • Bramfelder Straße 140
    • 22305  Hamburg
    • Germany
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  • start of 1:1-Block address scientific-contact
    • Institut für Medizinsoziologie, Versorgungsforschung und Rehabilitationswissenschaft (IMVR) der Humanwissenschaftlichen Fakultät und der Medizinischen Fakultät der Universität zu Köln
    • Ms.  Dr.  Nadine  Scholten 
    • Eupener Str. 129
    • 50933  Köln
    • Germany
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    • Institut für Medizinsoziologie, Versorgungsforschung und Rehabilitationswissenschaft (IMVR) der Humanwissenschaftlichen Fakultät und der Medizinischen Fakultät der Universität zu Köln
    • Ms.  Dr.  Nadine  Scholten 
    • Eupener Str. 129
    • 50933  Köln
    • Germany
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Sources of Monetary or Material Support

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    • Gemeinsamer Bundesausschuss - Innovationsausschuss
    • Gutenbergstraße 13
    • 10587  Berlin
    • Germany
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Status

  •   Recruiting ongoing
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Trial Publications, Results and other Documents

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* This entry means the parameter is not applicable or has not been set.