Contact information
Type
Scientific
Primary contact
Dr Celeste Maguire
ORCID ID
Contact details
Leiden University Medical Centre
Pediatrics
J6-S
Albinusdreef 2
P.O. Box 9600
Amsterdam
2300 RC
Netherlands
+31 (0)71 526 4082
c.m.maguire@lumc.nl
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
NTR258; ZonMw number: 2100.0072
Study information
Scientific title
Acronym
LDCS (the Leiden Developmental Care Study)
Study hypothesis
Developmental care has a positive outcome on the development and behaviour of very preterm infants and parental stress.
Ethics approval
Local ethics committee gave approval prior to recruitment.
Study design
Multicentre randomised active controlled parallel group trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Condition
Developmental and behavioural problems
Intervention
Two interventions (randomised control trials) in two consecutive phases:
Phase 1:
Reducing environmental stress through the use of covers over the incubators to decrease excess light and sound, the use of positional aids such as boundary supports and nests to promote a balance of flexion and extension, versus standard care.
Phase 2:
The use of the NIDCAP® behavioural assessment to create individual care plans for each infant and increasing parents' knowledge of premature infant behaviour and more directly involving them in the care of their baby, versus phase 1 intervention care.
Intervention type
Other
Phase
Not Applicable
Drug names
Primary outcome measures
During hospital admission:
1. Number of days requiring mechanical ventilation, CPAP or oxygen therapy
2. Number of days with reported apnoea episodes
3. Growth (weekly weight gain and increase of head circumference) morbidity
4. Parental Stress Scale-NICU (PSS-NICU)
5. The Nurse Parent Support Tool (NPST)
6. Mothers and Babies Scale (MABS)
At follow-up:
The infants participating in the study are examined at term age and after 1 and 2 years in the follow-up clinics of the LUMC and JKZ.
At term age:
A full medical history (including behavior) and physical examination, growth parameters, Prechtl neurological assessment and cerebral ultrasound.
At 1 year of age (corrected for prematurity):
1. Medical examination and growth parameters (weight, length and head circumference)
2. Touwen neurological assessment
3. Developmental outcomes: Bayley Mental and Psychomotor Developmental Index (BOS 2 - 30 Bayley developmental scales/BSID II)
4. Behavioural outcomes will be assessed through a parental questionnaire (ITSEA)
5. Parental stress through the Nijmeegse parental stress index (NOSI(K)) questionnaire
6. Health Related Quality of life through the (TAPCQOL) questionnaire
At 2 years of age (corrected for prematurity):
1. Medical examination and growth parameters (weight, length and head circumference)
2. Hempel neurological assessment
3. Developmental outcomes: Bayley Mental and Psychomotor Developmental Index (BOS 2 - 30 Bayley developmental scales/BSIDII)
4. Behavioral outcomes will be assessed through the CBCL (Child Behaviour list)
5. Parental stress through the NOSI(K)-Nijmeegse parental stress index
6. Health Related Quality of life through the (TAPCQOL) questionnaires
In phase 2: two additional questionnaires:
1. Three months: condition of infant (baby-KIPPPI)
2. Nine months: infant behavior (IBQ)
Secondary outcome measures
After inclusion of both interventions in the two phases a self-made questionnaire was given to the nursing and medical staff to assess the implementation of the NIDCAP intervention.
Overall trial start date
01/04/2000
Overall trial end date
01/12/2006
Reason abandoned
Eligibility
Participant inclusion criteria
All premature infants with a gestational age of 32 weeks or less admitted to the neonatal intensive care unit of Leiden University Medical Centre (LUMC) and Juliana Children's Hospital (JKZ) hospitals in the health region of Leiden, Delft, The Hague and Gouda for a period of at least five days.
Participant type
Patient
Age group
Neonate
Gender
Both
Target number of participants
360
Participant exclusion criteria
Infants of drug-addicted mothers and infants with cardiac problems or other major birth anomalies, or those requiring surgery
Recruitment start date
01/04/2000
Recruitment end date
01/12/2006
Locations
Countries of recruitment
Netherlands
Trial participating centre
Leiden University Medical Centre
Amsterdam
2300 RC
Netherlands
Sponsor information
Organisation
Leiden University Medical Centre (LUMC) (Netherlands)
Sponsor details
Albinusdreef 2
P.O. Box 9600
Leiden
2300 RC
Netherlands
Sponsor type
University/education
Website
Funders
Funder type
Research organisation
Funder name
The Netherlands Organisation for Health Research and Development (ZonMw) (Netherlands)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary
1. 2008 neonatal morbidity, neuromotor development, and growth results in http://www.ncbi.nlm.nih.gov/pubmed/18245399
2. 2009 Phase 1 intervention results in http://www.ncbi.nlm.nih.gov/pubmed/18703571
3. 2009 Phase 2 intervention results in http://www.ncbi.nlm.nih.gov/pubmed/19786441
Publication citations
-
Maguire CM, Veen S, Sprij AJ, Le Cessie S, Wit JM, Walther FJ, , Effects of basic developmental care on neonatal morbidity, neuromotor development, and growth at term age of infants who were born at <32 weeks., Pediatrics, 2008, 121, 2, e239-45, doi: 10.1542/peds.2007-1189.
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Maguire CM, Walther FJ, van Zwieten PH, Le Cessie S, Wit JM, Veen S, , No change in developmental outcome with incubator covers and nesting for very preterm infants in a randomised controlled trial., Arch. Dis. Child. Fetal Neonatal Ed., 2009, 94, 2, F92-7, doi: 10.1136/adc.2008.141002.
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Maguire CM, Walther FJ, Sprij AJ, Le Cessie S, Wit JM, Veen S, , Effects of individualized developmental care in a randomized trial of preterm infants <32 weeks., Pediatrics, 2009, 124, 4, 1021-1030, doi: 10.1542/peds.2008-1881.