The prevention of developmental and behavioural problems of very preterm infants and parental stress through the use of development care: an intervention program for infants and parents
ISRCTN | ISRCTN84995192 |
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DOI | https://doi.org/10.1186/ISRCTN84995192 |
Secondary identifying numbers | NTR258; ZonMw number: 2100.0072 |
- Submission date
- 20/12/2005
- Registration date
- 20/12/2005
- Last edited
- 14/10/2009
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Pregnancy and Childbirth
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Celeste Maguire
Scientific
Scientific
Leiden University Medical Centre
Pediatrics, J6-S
Albinusdreef 2
P.O. Box 9600
Amsterdam
2300 RC
Netherlands
Phone | +31 (0)71 526 4082 |
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c.m.maguire@lumc.nl |
Study information
Study design | Multicentre randomised active controlled parallel group trial |
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Primary study design | Interventional |
Secondary study design | Randomised controlled trial |
Study setting(s) | Hospital |
Study type | Treatment |
Scientific title | |
Study acronym | LDCS (the Leiden Developmental Care Study) |
Study objectives | Developmental care has a positive outcome on the development and behaviour of very preterm infants and parental stress. |
Ethics approval(s) | Local ethics committee gave approval prior to recruitment. |
Health condition(s) or problem(s) studied | 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 |
Primary outcome measure | 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 study start date | 01/04/2000 |
Completion date | 01/12/2006 |
Eligibility
Participant type(s) | Patient |
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Age group | Neonate |
Sex | Both |
Target number of participants | 360 |
Key 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. |
Key exclusion criteria | Infants of drug-addicted mothers and infants with cardiac problems or other major birth anomalies, or those requiring surgery |
Date of first enrolment | 01/04/2000 |
Date of final enrolment | 01/12/2006 |
Locations
Countries of recruitment
- Netherlands
Study participating centre
Leiden University Medical Centre
Amsterdam
2300 RC
Netherlands
2300 RC
Netherlands
Sponsor information
Leiden University Medical Centre (LUMC) (Netherlands)
University/education
University/education
Albinusdreef 2
P.O. Box 9600
Leiden
2300 RC
Netherlands
Website | http://www.lumc.nl/ |
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https://ror.org/027bh9e22 |
Funders
Funder type
Research organisation
The Netherlands Organisation for Health Research and Development (ZonMw) (Netherlands)
No information available
Results and Publications
Intention to publish date | |
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Individual participant data (IPD) Intention to share | No |
IPD sharing plan summary | Not provided at time of registration |
Publication and dissemination plan | Not provided at time of registration |
IPD sharing plan |
Study outputs
Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
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Results article | neonatal morbidity, neuromotor development, and growth results | 01/02/2008 | Yes | No | |
Results article | Phase 1 intervention results | 01/03/2009 | Yes | No | |
Results article | Phase 2 intervention results | 01/10/2009 | Yes | No |