The main question in the study isHow do moderately preterm infants and their parents differ from term, as well as extreme preterm infants in (a) development and self regulation skills of the infants, (b) interaction patterns and relationship between…
ID
Source
Brief title
Condition
- Structural brain disorders
- Neonatal and perinatal conditions
- Developmental disorders NEC
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The development of the children is assessed by their parents with the Ages and
Stages questionnaires (ASQ; Squires, Potter & Bricker, 1999) en de Ages and
Stages questionnaires - Social Emotional (ASQ-SE; Squires, Bricker & Twombly,
1999). The Infant Toddler Scales (ITSC; DeGangi et al., 1995) specifically
evaluates infants selfregulation skills. The Child Behavior Checklist (CBCL;
Achenbach & Rescorla, 2001) is used to study behaviourproblems. Development of
extreme preterm children is studied at the follow up clinic of the NICU with
the Bayley Scales of Infant Development (BSID II; Van der Meulen et al. 2002)
The General Health Questionnaire (GHQ; Koeter & Ormel, 1991) asks for well
being and stress of the mothers. The DS14 (Denollet, 2005) evaluates
personality characteristics as negative emotionality and social inhibition.
The Hospital Anxiety and Depression Scale (HADS, Spinhoven et al., 1997)
specifically focusses on anxiety and depressive complaints of the mothers.
Mother-infant interaction is observed during a daily meal and assessed with the
Emotional Availability Scales (EAS; Biringen) as well as an evaluation of
eating behaviour (Chatoor et al., 2000). The Working Model of the Child
Interview (WMCI; Zeanah, Benoit, Barton & Hirshberg, 1996) informs on the
quality of the relationship between mother and child.
Secondary outcome
The relationship between outcome of different measurement instruments will be
studied within the groups.
Background summary
Moderate preterm birth constitutes an insult for the still immature brain of
the infant. At 34 weeks gestational age the overall brain weight is only 65%
of term weight and dendritic arborization is still poor (Kinney, 2006). Despite
these risk factors and the large number of infants involved (6,2% is born
between 32 and 36.6 weeks in the Netherlands, around 11.000 infants per year),
information on developmental outcome of moderate preterm infants is scarce.
Research in our own region in The Netherlands was done on a group of 377
moderately preterm children (M=34.7, SD=1.2 weeks), without need for neonatal
intensive care, no dysmaturity and no congenital malformations, assessed around
8 years of age and compared with 183 term children concerning school situation,
IQ, concentration, behavior problems, ADHD and fear characteristics (Van Baar,
Knots et al., 2008 en Van Baar, Couturier et al., 2008). Results showed that
7,6% of the preterm group needs special education compared to 2,9% in the Dutch
population, and 19,5% versus 8,3% of the comparison children repeated a class.
Of the 76 preterm children with school problems (defined as special education
or grade retention), 65% were boys, their parents had a lower education level,
and they had a 100 grams lower mean birth weight than the preterm children
without school problems.
It was concluded that regulation difficulties are found in moderate preterm
children at school age. Further study should focus upon the early (interaction)
processes that shape regulative capacities during infancy, in relation to
parental characteristics, including maternal anxiety (Zelkowitz et al., 2007).
A structured follow up programme for moderately preterm children might be
necessary.
Comparisons of the outcome in moderately preterm children with term born
children, as well as with extreme preterm born children are important in view
of differences in brain maturation at birth, as well as differences in the
amount of parental stress and anxiety.
Study objective
The main question in the study is
How do moderately preterm infants and their parents differ from term, as well
as extreme preterm infants in (a) development and self regulation skills of the
infants, (b) interaction patterns and relationship between parent-infant dyads,
and (c) health and personality of their parents. A second question concerns the
groups differences that are found when the infants are 6-7 months of age
(corrected for prematurity); will these differences become stronger or weaker
when the children are older, at 18 - 23 months of age.
Study design
Two cohorts of 6-7 and 18 -23 months old children will be studied cross
sectionally using parent questionnaires concerning the development and
behaviour of the children and their own health and personality characteristics,
as well as and interview and an oberservation of parent child interaction. By
following up the youngest group also a longitudinal study of their development
is possible. The study aims to include 300 moderatly prterm children, 50
extreme preterm children and 150 term children.
Study burden and risks
The burden of this research is limited to answering questionnaires and
cooperating with a video recording of an interview, as well as cooperation of
mother and child with an observation during a daily routine. Parents are free
to stop participation if they decide to do so. If parents or children feel that
they need further support, couseling ot treatment, possibities for referral
will be checked within the network of cooperating hospitals.
Postbus 90153
5000 LE Tilburg
NL
Postbus 90153
5000 LE Tilburg
NL
Listed location countries
Age
Inclusion criteria
Birth between 32 and 32+6 weeks gestational age; birth before 30 weeks gestational age; term birth between 37 and 42 weeks gestational age; 6-7 months or 18-23 months old (corrected age)
Exclusion criteria
Congenital malformations, substance abuse, Neonatal intensive care admittance (except for the extreme preterm subgroup)
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
Register | ID |
---|---|
CCMO | NL20937.060.07 |