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
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

Leiden University Medical Centre
Pediatrics, J6-S
Albinusdreef 2
P.O. Box 9600
Amsterdam
2300 RC
Netherlands

Phone +31 (0)71 526 4082
Email c.m.maguire@lumc.nl

Study information

Study designMulticentre randomised active controlled parallel group trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Hospital
Study typeTreatment
Scientific title
Study acronymLDCS (the Leiden Developmental Care Study)
Study objectivesDevelopmental 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) studiedDevelopmental and behavioural problems
InterventionTwo 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 typeOther
Primary outcome measureDuring 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 measuresAfter 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 date01/04/2000
Completion date01/12/2006

Eligibility

Participant type(s)Patient
Age groupNeonate
SexBoth
Target number of participants360
Key inclusion criteriaAll 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 criteriaInfants of drug-addicted mothers and infants with cardiac problems or other major birth anomalies, or those requiring surgery
Date of first enrolment01/04/2000
Date of final enrolment01/12/2006

Locations

Countries of recruitment

  • Netherlands

Study participating centre

Leiden University Medical Centre
Amsterdam
2300 RC
Netherlands

Sponsor information

Leiden University Medical Centre (LUMC) (Netherlands)
University/education

Albinusdreef 2
P.O. Box 9600
Leiden
2300 RC
Netherlands

Website http://www.lumc.nl/
ROR logo "ROR" 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
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
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