Laseracupuncture as supportiv treatment for newborns with neonatal abstinence syndrome (NAS) caused by maternal substitutiontherapy
Organizational Data
- DRKS-ID:
- DRKS00004302
- Recruitment Status:
- Recruiting complete, study complete
- Date of registration in DRKS:
- 2012-08-10
- Last update in DRKS:
- 2015-12-09
- Registration type:
- Retrospective
Acronym/abbreviation of the study
No Entry
URL of the study
No Entry
Brief summary in lay language
Neonatal abstinence syndrome (NAS=neonatal abstinence syndrome) is well known since years in newborns of drug depending mothers or mothers following substitution therapy. The newborns develop 2-3 days after delivery the typical clinical signs of the NAS. Acupuncture is used since many years to treat adults with withdrawal symptoms, especially in the USA, and in some european countries following the NADA-Protocol. No literature is available about acupuncture therapy for newborns with NAS. Meanwhile laseracupuncture is a possible and well know method to treat children, who are not compatible to needleacupuncture. Therefore we decided laseracupuncture as a possible alternative, by using a IIIb-laser, called LABpen® MED 10 (wavelength 675nm, 10mW). The laseracupuncture therapy takes place every day-once a day by stimulate the ear and bodyacupuncure points,following international guidelines. The Finnegan score (-to evaluate the NAS symptoms-3 times a day ) and to optimize the therapy, the morphintherapy can be reduced or increased- to hold the newborn in a calm and relaxing steady state. The newborns were randomised in an intervention group (IG) and an control group(CG=without therapy) and could therefore after finishing the therapy-analysed.
Brief summary in scientific language
No Entry
Health condition or problem studied
- ICD10:
- F19.3
- Healthy volunteers:
- No Entry
Interventions, Observational Groups
- Arm 1:
- Studygroup 1 (Intervention group=acupuncture group): is treated with standardized morphintherapy and laseracupuncture. Standardized morphintherapy (morphindilution 0,04%): to evaluate the withdrawal symptoms the Finneganscore will take palce 3x times a day. Based on the daily Finnegan Score the morphintherapy will be reduced or will be increased. Start of the Opiatsubstitutiontherapy if 3 Scores >then 24 or an single score>12, Start with o,o5ml/kg(=2 drops/kg) diluted morphinsolution 0,04%)-with oral feeding every 4 hours(feeding: 6 times a day) or 3 hours (feeding: 8 times a day). Increasing the opiattherapy as long as the summ of 3 single scores<24. After 72 h in a "stable withdraw" postion- start to reduce the therapy, as described above. Laseracupuncture: once a day Bodyacupuncture: Large Intesine 4, Liver 3, Kidney 1, Kidney 3, and earacupuncture points: Sympathetic 51, Shen Men 55, Kidney 95, Liver 98, Lung 101. The laseracupuncture should take place every day, in a calm and relaxing time of the bay- best 1/2 or1 hour after feeding and after administration of the morphinsolution. The laseracupunturetherapy will be carried out daily, as long as the infant receives the oral morphintherapy.
- Arm 2:
- Studygroup 2 (Control group)=treated by standardizied morphindilution. Standardized morphintherapy (morphindilution 0,04%): to evaluate the withdrawal symptoms the Finnegan-score will take place 3x times a day. Based on the daily Finnegan Score the morphintherapy will be reduced or will be increased. Start of the Opiatsubstitutiontherapy if the amount of 3 Scores >then 24 or an single score>12, Start with o,o5ml/kg(=2 drops/kg) diluted morphinsolution (0,04%)-with oral feeding every 4 hours (feeding: 6 times a day) or 3 hours (feeding: 8 times a day). Increasing the opiattherapy as long as the amount of 3 single scores<24. After 72 h in a stable situation-without withdrawal symptoms (amount of 3 single Finnegan Score<24)- start to reduce the therapy, as described above. No laseracupuncture in the control group.
Endpoints
- Primary outcome:
- the duration of the therapytreatment of the morphintherapy between the IG and CG should be compared
- Secondary outcome:
- The amount of the morphintherapy between groups should be analyzed. Also the "active" earacupuncturepoints (identified by an neuronal pen-(PS 3 ©Silberbauer, Vienna, Austria) of both groups should be analyzed.
Study Design
- Purpose:
- Treatment
- Allocation:
- Randomized controlled study
- Control:
-
- Active control (effective treatment of control group)
- Phase:
- N/A
- Study type:
- Interventional
- Mechanism of allocation concealment:
- No Entry
- Blinding:
- Yes
- Assignment:
- Parallel
- Sequence generation:
- No Entry
- Who is blinded:
-
- Assessor
- Caregiver
- Data analyst
Recruitment
- Recruitment Status:
- Recruiting complete, study complete
- Reason if recruiting stopped or withdrawn:
- No Entry
Recruitment Locations
- Recruitment countries:
-
- Austria
- Number of study centers:
- Monocenter study
- Recruitment location(s):
-
- University medical center Neonatologie Graz
Recruitment period and number of participants
- Planned study start date:
- No Entry
- Actual study start date:
- 2009-07-01
- Planned study completion date:
- No Entry
- Actual Study Completion Date:
- 2015-10-28
- Target Sample Size:
- 30
- Final Sample Size:
- 30
Inclusion Criteria
- Sex:
- All
- Minimum Age:
- 1 Days
- Maximum Age:
- 3 Months
- Additional Inclusion Criteria:
- Newborns (term and preterm) with the anamnesis and +/- clinical signs of neonatal abstinence syndrome
Exclusion Criteria
genetic disorders and malformations
Addresses
Primary Sponsor
- Address:
- Abteilung für Neonatologie Univ.Klinik für Kinder und JugendheilkundeProf Berndt UrlesbergerAuenbruggerplatz 308036 GrazAustria
- Telephone:
- +4331638512624
- Fax:
- +4331638514445
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- http://www.neonatologie.com
- Investigator Sponsored/Initiated Trial (IST/IIT):
- Yes
Contact for Scientific Queries
- Address:
- Univ. Klinik für Kinder und JugendheilkundeDr Wolfgang RaithAuenbruggerplatz 30A-8036 GrazAustria
- Telephone:
- +4331638580599
- Fax:
- +433163851445
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- http://www.neonatologie.com
Contact for Public Queries
- Address:
- Univ. Klinik für Kinder und JugendheilkundeDr Wolfgang RaithAuenbruggerplatz 30A-8036 GrazAustria
- Telephone:
- +4331638580599
- Fax:
- +4331638580599
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- http://www.neonatologie.com
Principal Investigator
- Address:
- Univ. Klinik für Kinder und JugendheilkundeDr Wolfgang RaithAuenbruggerplatz 30A-8036 GrazAustria
- Telephone:
- +4331638580599
- Fax:
- +433163851445
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- http://www.neonatologie.com
Sources of Monetary or Material Support
Institutional budget, no external funding (budget of sponsor/PI)
- Address:
- LKH Universitätsklinikum GrazAuenbrugger Platz 18036 GrazAustria
- Telephone:
- No Entry
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- http://www.lkh-graz.at
Ethics Committee
Address Ethics Committee
- Address:
- Ethikkommission der Medizinischen Universität Graz LKH-Universitätsklinikum [ IRB00002556 Ethikkommission der Medizinischen Universität Graz]Auenbruggerplatz 2, 3.OGA-8036 GrazAustria
- Telephone:
- (+43/0)316/385-13928,
- Fax:
- (+43/0)316/385-14348
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- http://www.meduni-graz.at/ethikkommission/Graz/
Vote of leading Ethics Committee
- Vote of leading Ethics Committee
- Date of ethics committee application:
- 2009-03-30
- Ethics committee number:
- 20-293 ex 08/09
- Vote of the Ethics Committee:
- Approved
- Date of the vote:
- 2009-07-01
Further identification numbers
- Other primary registry ID:
- No Entry
- EudraCT Number:
- No Entry
IPD - Individual Participant Data
- Do you plan to make participant-related data (IPD) available to other researchers in an anonymized form?:
- No Entry
- IPD Sharing Plan:
- No Entry
Study protocol and other study documents
- Study protocols:
- No Entry
- Study abstract:
- No Entry
- Other study documents:
- Teilzusammenfassung des bisherigen Pilotprojektes
- Background literature:
- No Entry
- Related DRKS studies:
- No Entry
Publication of study results
- Planned publication:
- No Entry
- Publikationen/Studienergebnisse:
- Vorstellung der Studie anhand eines case reports
- publizierte RCT
- Date of first publication of study results:
- No Entry
- DRKS entry published for the first time with results:
- No Entry
Basic reporting
- Basic Reporting / Results tables:
- No Entry
- Brief summary of results:
- No Entry