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
Protocol serial number	NTR258; ZonMw number: 2100.0072
Sponsor	Leiden University Medical Centre (LUMC) (Netherlands)
Funder	The Netherlands Organisation for Health Research and Development (ZonMw) (Netherlands)

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

Primary study design	Interventional
Study design	Multicentre randomised active controlled parallel group trial
Secondary study design	Randomised controlled trial
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(s)	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)
Key secondary outcome measure(s)	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.
Completion date	01/12/2006

Eligibility

Participant type(s)	Patient
Age group	Neonate
Sex	All
Target sample size at registration	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

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	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