Preterm InfantsNCT00222456
Project Early Intervention 2000
A study testing Sensitizing parents in people with Preterm Infants and Parenting Stress, run by University Hospital of North Norway at 1 site in Norway.
Trial summary
The purpose of this study is to examine whether an early intervention program may improve cognitive and behavioral short and longterm outcome in preterm infants. Read more about this study
- Who is it for?
- Ages 0 years and olderHealthy volunteers can take part
- Conditions the study is for
- Preterm Infants, Parenting Stress
- What is being tested?
- Sensitizing parents
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 210 participants
- Where
- 1 siteNorway
- Study dates
- Mar 1999to Sep 2008
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 0 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Birth weight < 2000 gram
Who cannot join
- Congenital anomalies
- Non-Norwegian speaking mother
- Triplets
Trial locations and contacts
1 site in 1 country.
Norway1 site
Pediatric Dept. University Hospital of North Norway
Tromsø, N-9038
About this study
Official title: Can Early Intervention Prevent Developmental Disturbances/Delays and Improve the Health of Children Born Prematurely
The purpose of this study is to examine whether an early intervention program may improve cognitive and behavioral short and longterm outcome in preterm infants.
Read the detailed description
Advances in neonatal medicine has increased the survival of infants with low birth weight. Repeatedly it has been documented an increased prevalence of psychological and medical problems in this group of children. Frequent psychological problems are intellectual disturbances, language delays, behavior problems like ADHD and learning difficulties. Usual medical problems are subnormal growth, various illnesses and neuro-developmental problems.
The high prevalence of psychological and medical risks makes this group of children target for follow-up assessments and early intervention.
The main aim of the project is to investigate whether sensitizing the parents will reduce the incidence of developmental disturbances in a group of low birth weight infants compared to a control group.
The study is carried out as a cooperation between the Departments of child- and adolescent psychiatry and pediatrics of the University Hospital in Tromsoe in Northern - Norway. 140 premature infants with birth weight less than 2000 grams are randomly distributed to an intervention and control group. In addition 70 full term infants are selected to another control.
A slightly modified version of The Vermont Intervention Program for Low Birth Weight Infants is applied to the infants in the intervention group, where the parents receive one hour of instruction from a special trained neonatal nurse one hour per day the last week before discharge (infant = 37 weeks G.A.). In addition, the parents receive four home visits during the the three first months after discharge.
Psychological and medical assessments are undertaken at ages: 36 weeks G.A., 6 months, 1, 2 3 5 years corrected for prematurity
- Conditions
- Preterm Infants, Parenting Stress
- Being tested
- Sensitizing parents
- Keywords
- preterm infants, early intervention, outcome, behavioral problems, parenting stress
- Medical subject headings
- Problem Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sensitizing parentsBehavioural
What is being measured
The primary outcome is the main question the study is designed to answer.
Cognitive and behavioral outcome
Parenting Stress
Secondary outcomes (1)
Neurodevelopmental outcome
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2005 (estimated)
- Study startMar 1999
- Study completionSep 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Preterm InfantsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 210 participants
Sponsor and investigators
- Lead sponsor
- University Hospital of North Norway
- Sponsor type
- University, hospital or other
- Collaborators
- The Research Council of Norway, Norwegian Council for Mental Health, Norwegian Foundation for Health and Rehabilitation, The Northern Norway Health Authority, University of Tromso
- Investigators
- John Ronning, PhD, Study chair, University of Tromsoe, Norway
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00222456
- Sponsor's protocol ID
- SFP 46-04
- Other IDs
- NSD-codes: MN990199, NFR-number: 132506/320, NDI 98/2638-2 TFE/- 5
- Status last verified
- Sep 2005
- First submitted
- 15 Sep 2005
- Last updated
- 22 Sep 2005
- Results posted
- No
Publications
Landsem IP, Handegard BH, Ulvund SE, Kaaresen PI, Ronning JA. Early intervention influences positively quality of life as reported by prematurely born children at age nine and their parents; a randomized clinical trial. Health Qual Life Outcomes. 2015 Feb 22;13:25. doi: 10.1186/s12955-015-0221-9.
PubMed 25888838Landsem IP, Handegard BH, Tunby J, Ulvund SE, Ronning JA. Early intervention program reduces stress in parents of preterms during childhood, a randomized controlled trial. Trials. 2014 Oct 4;15:387. doi: 10.1186/1745-6215-15-387.
PubMed 25282345Hauglann L, Handegaard BH, Ulvund SE, Nordhov M, Ronning JA, Kaaresen PI. Cognitive outcome of early intervention in preterms at 7 and 9 years of age: a randomised controlled trial. Arch Dis Child Fetal Neonatal Ed. 2015 Jan;100(1):F11-6. doi: 10.1136/archdischild-2014-306496. Epub 2014 Sep 23.
PubMed 25249191Nordhov SM, Ronning JA, Ulvund SE, Dahl LB, Kaaresen PI. Early intervention improves behavioral outcomes for preterm infants: randomized controlled trial. Pediatrics. 2012 Jan;129(1):e9-e16. doi: 10.1542/peds.2011-0248. Epub 2011 Dec 19.
PubMed 22184645Nordhov SM, Ronning JA, Dahl LB, Ulvund SE, Tunby J, Kaaresen PI. Early intervention improves cognitive outcomes for preterm infants: randomized controlled trial. Pediatrics. 2010 Nov;126(5):e1088-94. doi: 10.1542/peds.2010-0778. Epub 2010 Oct 11.
PubMed 20937650
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2005. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Can Early Intervention Prevent Developmental Disturbances/Delays and Improve the Health of Children Born Prematurely
- ClinicalTrials.gov ID
- NCT00222456
- Acronym / sponsor ID
- SFP 46-04
- Conditions
- Preterm Infants, Parenting Stress
- Keywords
- preterm infants, early intervention, outcome, behavioral problems, parenting stress
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 210 participants
- Lead sponsor
- University Hospital of North NorwayUniversity, hospital or other
- Collaborators
- The Research Council of Norway, Norwegian Council for Mental Health, Norwegian Foundation for Health and Rehabilitation, The Northern Norway Health Authority, University of Tromso
- Study start
- Mar 1999
- Study completion
- Sep 2008
- First posted
- 22 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to examine whether an early intervention program may improve cognitive and behavioral short and longterm outcome in preterm infants.
Detailed description
Advances in neonatal medicine has increased the survival of infants with low birth weight. Repeatedly it has been documented an increased prevalence of psychological and medical problems in this group of children. Frequent psychological problems are intellectual disturbances, language delays, behavior problems like ADHD and learning difficulties. Usual medical problems are subnormal growth, various illnesses and neuro-developmental problems.
The high prevalence of psychological and medical risks makes this group of children target for follow-up assessments and early intervention.
The main aim of the project is to investigate whether sensitizing the parents will reduce the incidence of developmental disturbances in a group of low birth weight infants compared to a control group.
The study is carried out as a cooperation between the Departments of child- and adolescent psychiatry and pediatrics of the University Hospital in Tromsoe in Northern - Norway. 140 premature infants with birth weight less than 2000 grams are randomly distributed to an intervention and control group. In addition 70 full term infants are selected to another control.
A slightly modified version of The Vermont Intervention Program for Low Birth Weight Infants is applied to the infants in the intervention group, where the parents receive one hour of instruction from a special trained neonatal nurse one hour per day the last week before discharge (infant = 37 weeks G.A.). In addition, the parents receive four home visits during the the three first months after discharge.
Psychological and medical assessments are undertaken at ages: 36 weeks G.A., 6 months, 1, 2 3 5 years corrected for prematurity
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 0 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Birth weight < 2000 gram
Key exclusion criteria (3 listed)
- Congenital anomalies
- Non-Norwegian speaking mother
- Triplets
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sensitizing parents | Behavioural | – |
Primary outcome
Cognitive and behavioral outcome
Parenting Stress
1 secondary outcome
Neurodevelopmental outcome
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Sep 2005.
- Derived from this study: PubMed 25888838Landsem IP, Handegard BH, Ulvund SE, Kaaresen PI, Ronning JA. Early intervention influences positively quality of life as reported by prematurely born children at age nine and their parents; a randomized clinical trial. Health Qual Life Outcomes. 2015 Feb 22;13:25. doi: 10.1186/s12955-015-0221-9.
- Derived from this study: PubMed 25282345Landsem IP, Handegard BH, Tunby J, Ulvund SE, Ronning JA. Early intervention program reduces stress in parents of preterms during childhood, a randomized controlled trial. Trials. 2014 Oct 4;15:387. doi: 10.1186/1745-6215-15-387.
- Derived from this study: PubMed 25249191Hauglann L, Handegaard BH, Ulvund SE, Nordhov M, Ronning JA, Kaaresen PI. Cognitive outcome of early intervention in preterms at 7 and 9 years of age: a randomised controlled trial. Arch Dis Child Fetal Neonatal Ed. 2015 Jan;100(1):F11-6. doi: 10.1136/archdischild-2014-306496. Epub 2014 Sep 23.
- Derived from this study: PubMed 22184645Nordhov SM, Ronning JA, Ulvund SE, Dahl LB, Kaaresen PI. Early intervention improves behavioral outcomes for preterm infants: randomized controlled trial. Pediatrics. 2012 Jan;129(1):e9-e16. doi: 10.1542/peds.2011-0248. Epub 2011 Dec 19.
- Derived from this study: PubMed 20937650Nordhov SM, Ronning JA, Dahl LB, Ulvund SE, Tunby J, Kaaresen PI. Early intervention improves cognitive outcomes for preterm infants: randomized controlled trial. Pediatrics. 2010 Nov;126(5):e1088-94. doi: 10.1542/peds.2010-0778. Epub 2010 Oct 11.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
John Ronning, PhD study chair
University of Tromsoe, Norway
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sensitizing parents in people with Preterm Infants and Parenting Stress, run by University Hospital of North Norway at 1 site in Norway.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Sep 2005. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cognitive and behavioral outcome. The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00222456, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Sep 2005; AzTrials last refreshed its copy on 27 Oct 2026.