Condition category
Pregnancy and Childbirth
Date applied
20/12/2005
Date assigned
20/12/2005
Last edited
14/10/2009
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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

http://www.lumc.nl/

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

  1. 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.

  2. 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.

  3. 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.

Additional files

Editorial Notes