Trial document




drksid header

  DRKS00008306

Trial Description

start of 1:1-Block title

Title

Neurological Assessment of Neonates with Neonatal Abstinence Syndrome(NAS) based on the principles of Prechtl's General Movements (GMs)

end of 1:1-Block title
start of 1:1-Block acronym

Trial Acronym

[---]*

end of 1:1-Block acronym
start of 1:1-Block url

URL of the Trial

[---]*

end of 1:1-Block url
start of 1:1-Block public summary

Brief Summary in Lay Language

As in other countries, in Austria, too, the numbers of neonates suffering from NAS (Neonatal Abstinence Syndrome) are constantly on the rise. While in the years 1998 to 2004, the average figure of in-patient children per year diagnosed with NAS was 2.6, since 2005 this figure has been found to be significantly higher at an average of 7.5. In accordance with the international NAS standards, the children are treated with the application of a 0.04% morphine solution. Of the children affected, altogether four videos are to be taken in the course of their postnatal stay in hospital and, additionally, one video 12 weeks after their calculated date of delivery. The purpose of the videos is to reveal the quality of the spontaneous movements classified according to Prechtl, this analysis allowing for a statement about the expected neurological deficits.
Furthermore, through this approach, it should be clarified whether or not the analysis according to Prechtl is suitable to be used, in the future, also for an evaluation of results of a drug-based morphine therapy.

end of 1:1-Block public summary
start of 1:1-Block scientific synopsis

Brief Summary in Scientific Language

The maternal consumption of addictive drugs during pregnancy often goes hand in hand with postnatal withdrawal symptoms in the neonate (Neonatal Abstinence Syndrome, or NAS for short); the symptoms are classified using the Finnegan Score. Among the classical signs of NAS are found myoclonus while at rest and under the influence of disturbance, raised muscle tone and hyperactive reflexes , sweating, unstable body temperature, blocked nose, sustained high-pitched crying, short sleep phases and, rarely, cramps. On top of that, tachypnoea and apnoea may occur. Many children develop gastro-intestinal symptoms with vomiting conditions and watery diarrhoea – often to the point of making oral food intake impossible. Thus, together with drinking problems resulting from the neonates’ restlessness, in extreme cases the placing of a nasogastric tube or parenteral nutrition become necessary.
On top of an overall social view of the problem from the point of view of medical economics, the main focus of research is on optimum therapy for the affected neonates. In fact, there are already quite a number of studies exploring neonatal NAS therapy. However, a long-term prognosis based on both maternal and neonatal therapy has so far not been researched.
The assessment of the general movements, or GMs, for short, on the basis of video analyses according to Prechtl has proved to be a highly reliable method for the discovery of any later neurological deficits very early on (approx. 10 to 15 weeks after the calculated date of delivery). GMs are endogenously generated spontaneous movements characterised by a high variability of sequence, amplitude, velocity, power and intensity. The neonate is not at all irritated by the qualitative assessment of the GMs, and they can therefore easily be undertaken during intensive care. Early intervention offers the great advantage of dtecting a high-risk neurological condition at a very early stage. In their studies, Coyle et al. have elaborated a score which allows the neonatal neurological behaviour of NAS children to be assessed in a manner similar to the analysis achieved according to Prechtl, with one sub-point being the evaluation of the quality of the movements. In this way, it was revealed how the quality of the movements does, in fact, correlate to the grade of severity of the NAS. Early therapies may be accompanied by the methods of the qualitative assessment of the GMs, and their efficiency can thus be continuously evaluated. Palchik et al. have been able to show an unfavourable developmental neurological outcome in children following maternal opiate abuse or maternal HIV infection by assessing the quality of the infant GMs. However, it would be of great importance to apply the method of GM analysis in children who display NAS systems without, at the same time, being subject also to other influential factors. It still remains to be seen what impact a maternal HIV infection has on infant development.
In the light of all that, the problems caused by neonatal addictive drug withdrawal symptoms continue to represent a great medical challenge and social endeavour. Facing the problem from the medical point of view, prospective examinations in the perinatal period should be combined with a long-term analysis of the development of the children concerned.


References:

Prechtl HFR, Einspieler C, Cioni G, Bos AF, Ferrari F, Sontheimer D. Lancet 1997 An early marker for neurological deficits after perinatal brain lesions. 33349: 1361-3.
Prechtl HFR. Qualitative changes of spontaneous movements in fetus and preterm infant are a marker of neurological dysfunction. Early Hum Dev 1990; 23:151-8
Coyle MG, Salisbury AL, Lester BM, Jones HE, Lin H, Graf-Rohrmeister K, Fischer G. Neonatal neurobehavior effects following buprenorphine versus methadone exposure. Addiction. 2012 Nov; 107 Suppl 1:63-73.
Palchik AB, Einspieler C, Evstafeyeva IV, Talisa VB, Marschik PB. Intra-uterine exposure to maternal opiate abuse and HIV: the impact on the developing nervous system. Early Hum Dev. 2013 Apr; 89(4):229-35.

end of 1:1-Block scientific synopsis
start of 1:1-Block organizational data

Organizational Data

  •   DRKS00008306
  •   2015/05/21
  •   [---]*
  •   yes
  •   Approved
  •   27-145ex14/15, Ethikkommission der Medizinschen Universität Graz
end of 1:1-Block organizational data
start of 1:n-Block secondary IDs

Secondary IDs

  • [---]*
end of 1:n-Block secondary IDs
start of 1:N-Block indications

Health Condition or Problem studied

  •   P96.1 -  Neonatal withdrawal symptoms from maternal use of drugs of addiction
end of 1:N-Block indications
start of 1:N-Block interventions

Interventions/Observational Groups

  •   Observation of GMs (general movements) are performed during their postnatal hospital stay (4 Videos) and an additional video recording 12 weeks after the calculated birth date.
  •   Comparison of GMs of mature healthy newborns
end of 1:N-Block interventions
start of 1:1-Block design

Characteristics

  •   Non-interventional
  •   Observational study
  •   Non-randomized controlled trial
  •   Open (masking not used)
  •   [---]*
  •   Historical
  •   Basic research/physiological study
  •   Other
  •   N/A
  •   N/A
end of 1:1-Block design
start of 1:1-Block primary endpoint

Primary Outcome

Trend analysis of the four postnatal videos GM's (General Movements) inclusive the one video 12 weeks after their calculated date of delivery.

end of 1:1-Block primary endpoint
start of 1:1-Block secondary endpoint

Secondary Outcome

end of 1:1-Block secondary endpoint
start of 1:n-Block recruitment countries

Countries of Recruitment

  •   Austria
end of 1:n-Block recruitment countries
start of 1:n-Block recruitment locations

Locations of Recruitment

  • Medical Center 
end of 1:n-Block recruitment locations
start of 1:1-Block recruitment

Recruitment

  •   Actual
  •   2015/07/01
  •   20
  •   Monocenter trial
  •   National
end of 1:1-Block recruitment
start of 1:1-Block inclusion criteria

Inclusion Criteria

  •   Both, male and female
  •   1   Days
  •   10   Days
end of 1:1-Block inclusion criteria
start of 1:1-Block inclusion criteria add

Additional Inclusion Criteria

Newborns with Neonatal Abstinence Syndrome

end of 1:1-Block inclusion criteria add
start of 1:1-Block exclusion criteria

Exclusion Criteria

end of 1:1-Block exclusion criteria
start of 1:n-Block addresses

Addresses

  • start of 1:1-Block address primary-sponsor
    • Univ. Klinik für Kinder und Jugendheilkunde
    • Mr.  Dr  Wolfgang  Raith 
    • Auenbruggerplatz 30
    • 8036  Graz
    • Austria
    end of 1:1-Block address primary-sponsor
    start of 1:1-Block address contact primary-sponsor
    end of 1:1-Block address contact primary-sponsor
  • start of 1:1-Block address other
    • Univ. Klinik für Kinder und Jugendheilkunde
    • Mr.  Dr  Wolfgang  Raith 
    • Auenbruggerplatz 30
    • 8036  Graz
    end of 1:1-Block address other
    start of 1:1-Block address contact other
    end of 1:1-Block address contact other
  • start of 1:1-Block address scientific-contact
    • Univ. Klinik für Kinder und Jugendheilkunde
    • Mr.  Dr  Wolfgang  Raith 
    • Auenbruggerplatz 30
    • 8036  Graz
    • Austria
    end of 1:1-Block address scientific-contact
    start of 1:1-Block address contact scientific-contact
    end of 1:1-Block address contact scientific-contact
  • start of 1:1-Block address public-contact
    • Univ. Klinik für Kinder und Jugendheilkunde
    • Mr.  Dr  Wolfgang  Raith 
    • Auenbruggerplatz 30
    • 8036  Graz
    • Austria
    end of 1:1-Block address public-contact
    start of 1:1-Block address contact public-contact
    end of 1:1-Block address contact public-contact
end of 1:n-Block addresses
start of 1:n-Block material support

Sources of Monetary or Material Support

  • start of 1:1-Block address materialSupport
    • Univ. Klinik für Kinder und Jugendheilkunde
    • Mr.  Dr  Wolfgang  Raith 
    • Auenbruggerplatz 30
    • 8036  Graz
    • Austria
    end of 1:1-Block address materialSupport
    start of 1:1-Block address contact materialSupport
    end of 1:1-Block address contact materialSupport
end of 1:n-Block material support
start of 1:1-Block state

Status

  •   Recruiting complete, follow-up continuing
  •   [---]*
end of 1:1-Block state
start of 1:n-Block publications

Trial Publications, Results and other Documents

  • [---]*
end of 1:n-Block publications
* This entry means the parameter is not applicable or has not been set.