DevelopmentNCT00883974
Sensitivity Training For Parents of Preterm Infants
A study testing Sensitivity Training in people with Development and Preterm Birth, run by University of Melbourne at 2 sites in Australia.
Trial summary
Immediately following birth, preterm infants face a period of stressful environmental inputs, which may have negative consequences on early brain development and subsequent neurobehavioral outcomes. This study aimed to assess the effectiveness of training parents in reducing stressful experiences early in life. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Development, Preterm Birth
- What is being tested?
- Sensitivity Training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 2 sitesAustralia
- Study dates
- Apr 2004to Sep 2005
- 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 Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- > 30 weeks gestation
Who cannot join
- insufficient English
- congenital abnormality
- triplets and higher multiple births
- residence > 100 km from study site
Trial locations and contacts
2 sites in 1 country.
Australia2 sites
Austin Health
Melbourne, Victoria, 3081
Jeannette Milgrom
Melbourne, Victoria, VIC 3081
About this study
Official title: Early Sensitivity Training for Parents of Preterm Infants: Impact on the Developing Brain
Immediately following birth, preterm infants face a period of stressful environmental inputs, which may have negative consequences on early brain development and subsequent neurobehavioral outcomes. This study aimed to assess the effectiveness of training parents in reducing stressful experiences early in life. The investigators hypothesized that this intervention would insulate preterm infants from the harmful effects of acute and chronic stress, which in turn would result in enhanced brain development. The primary aim of the current study was to investigate if this intervention was associated with improved brain development measured by magnetic resonance imaging (MRI) at term-equivalent age. A secondary aim was to assess some possible short-term medical benefits.
Read the detailed description
A randomized controlled trial of a parental sensitivity training program involving 45 women with infants born < 30 weeks gestational age. The intervention consisted of 10 individual sessions in the Neonatal Intensive Care Unit (NICU). Post-intervention, at term-equivalent age (40 weeks postmenstrual age), magnetic resonance (MR) imaging was performed to evaluate brain structure and development. Quantitative volumetric techniques were used to estimate overall and regional brain volumes for different tissue types including cerebrospinal fluid (CSF), cortical grey matter (CGM), deep nuclear grey matter (DNGM), unmyelinated white matter (UWM) and myelinated white matter (MWM). Diffusion tensor imaging (DTI) was used to evaluate the integrity and maturation of white matter by apparent diffusion coefficient (ADC) and fractional anisotropy (FA).
- Conditions
- Development, Preterm Birth
- Being tested
- Sensitivity Training
- Keywords
- preterm bith, neurodevelopment, sensitivity training, magnetic resonance imaging (MRI), Infant neurodevelopment following preterm birth
- Medical subject headings
- Premature Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sensitivity TrainingBehavioural
The parent sensitivity training program was delivered in NICU (9 sessions) with a home-booster session. Therapists worked with parents following a manualized protocol. Targets of intervention included: recognizing signs of infant stress, "shut-down" mechanisms, alert-available behavior, motor behaviors, facial expressions,posture/muscle tone; graded stimulation; how to optimize interactions; touch, movement and massage; "kangaroo care" (nesting infants skin-to-skin against their mother); vocal, visual and multi-sensory stimulation; normalizing parental feelings; challenging dysfunctional thinking, and diary keeping.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Not described Receives: Behavioral: Sensitivity Training |
| 2 | No intervention | Standard Neonatal Intensive Care Unit (NICU) procedures for the care of pre-term infants |
What is being measured
The primary outcome is the main question the study is designed to answer.
Functional magnetic resonance imaging
Measured: Preterm infants at full-term equivalent age (40 weeks post-menstrual age)
Secondary outcomes (1)
Short-term medical stability
Measured: Birth to full-term eqivalent age (40 weeks post-menstrual age)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2009 (estimated)
- Study startApr 2004
- Primary completionAug 2005
- Study completionSep 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for DevelopmentStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Melbourne
- Sponsor type
- University, hospital or other
- Collaborators
- The Financial Markets Foundation for Children
- Investigators
- Jeannette Milgrom, PhD, Principal investigator, University of Melbourne/Austin Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00883974
- Sponsor's protocol ID
- Preterm Sensitivity Training
- Status last verified
- Oct 2009
- First submitted
- 17 Apr 2009
- Last updated
- 29 Oct 2009
- Results posted
- No
- Data monitoring committee
- No
Publications
Milgrom J, Newnham C, Anderson PJ, Doyle LW, Gemmill AW, Lee K, Hunt RW, Bear M, Inder T. Early sensitivity training for parents of preterm infants: impact on the developing brain. Pediatr Res. 2010 Mar;67(3):330-5. doi: 10.1203/PDR.0b013e3181cb8e2f.
PubMed 19952869
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Sensitivity Training for Parents of Preterm Infants: Impact on the Developing Brain
- ClinicalTrials.gov ID
- NCT00883974
- Acronym / sponsor ID
- Preterm Sensitivity Training
- Conditions
- Development, Preterm Birth
- Keywords
- preterm bith, neurodevelopment, sensitivity training, magnetic resonance imaging (MRI), Infant neurodevelopment following preterm birth
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- University of MelbourneUniversity, hospital or other
- Collaborators
- The Financial Markets Foundation for Children
- Study start
- Apr 2004
- Primary completion
- Aug 2005 (actual)
- Study completion
- Sep 2005 (actual)
- First posted
- 20 Apr 2009 (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.
Immediately following birth, preterm infants face a period of stressful environmental inputs, which may have negative consequences on early brain development and subsequent neurobehavioral outcomes. This study aimed to assess the effectiveness of training parents in reducing stressful experiences early in life. The investigators hypothesized that this intervention would insulate preterm infants from the harmful effects of acute and chronic stress, which in turn would result in enhanced brain development. The primary aim of the current study was to investigate if this intervention was associated with improved brain development measured by magnetic resonance imaging (MRI) at term-equivalent age. A secondary aim was to assess some possible short-term medical benefits.
Detailed description
A randomized controlled trial of a parental sensitivity training program involving 45 women with infants born < 30 weeks gestational age. The intervention consisted of 10 individual sessions in the Neonatal Intensive Care Unit (NICU). Post-intervention, at term-equivalent age (40 weeks postmenstrual age), magnetic resonance (MR) imaging was performed to evaluate brain structure and development. Quantitative volumetric techniques were used to estimate overall and regional brain volumes for different tissue types including cerebrospinal fluid (CSF), cortical grey matter (CGM), deep nuclear grey matter (DNGM), unmyelinated white matter (UWM) and myelinated white matter (MWM). Diffusion tensor imaging (DTI) was used to evaluate the integrity and maturation of white matter by apparent diffusion coefficient (ADC) and fractional anisotropy (FA).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Behavioral: Sensitivity Training |
| 2 | No intervention | –Standard Neonatal Intensive Care Unit (NICU) procedures for the care of pre-term infants |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- > 30 weeks gestation
Key exclusion criteria (4 listed)
- insufficient English
- congenital abnormality
- triplets and higher multiple births
- residence > 100 km from study site
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 |
|---|---|---|
| Sensitivity TrainingThe parent sensitivity training program was delivered in NICU (9 sessions) with a home-booster session. Therapists worked with parents following a manualized protocol. Targets of intervention included: recognizing signs of infant stress, "shut-down" mechanisms, alert-available behavior, motor behaviors, facial expressions,posture/muscle tone; graded stimulation; how to optimize interactions; touch, movement and massage; "kangaroo care" (nesting infants skin-to-skin against their mother); vocal, visual and multi-sensory stimulation; normalizing parental feelings; challenging dysfunctional thinking, and diary keeping. | Behavioural | 1 |
Primary outcome
Functional magnetic resonance imaging
Time frame: Preterm infants at full-term equivalent age (40 weeks post-menstrual age)
1 secondary outcome
Short-term medical stability
Time frame: Birth to full-term eqivalent age (40 weeks post-menstrual age)
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 29 Oct 2009.
- Derived from this study: PubMed 19952869Milgrom J, Newnham C, Anderson PJ, Doyle LW, Gemmill AW, Lee K, Hunt RW, Bear M, Inder T. Early sensitivity training for parents of preterm infants: impact on the developing brain. Pediatr Res. 2010 Mar;67(3):330-5. doi: 10.1203/PDR.0b013e3181cb8e2f.
Related trials for Development
Not yet recruitingObservational study
Prevalence and Development of Liver Dysfunction in Hematopoietic Stem Cell Transplant
Hematopoietic Stem Cell Transplant
RecruitingPhase 1
Cannabidiol (CBD) in Adults With ASD
Autism Spectrum Disorder
RecruitingObservational study
Impact of Vestibular Function on Deaf Infants' Activities of Daily Living
Vestibular Dysfunction, Hearing Loss
Active, not recruiting
A Pilot Factorial Trial of an Integrated Lifestyle Intervention
Physical Inactivity, Overweight and Obesity
Not yet recruitingObservational study
Development and Multicenter Validation of an Explainable System for Neonatal ARDS-Compatible Phenotyping
Acute Respiratory Distress Syndrome
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.
Jeannette Milgrom, PhD principal investigator
University of Melbourne/Austin Health
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sensitivity Training in people with Development and Preterm Birth, run by University of Melbourne at 2 sites in Australia.
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 4 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 29 Oct 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Australia. 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?
Functional magnetic resonance imaging (time frame: Preterm infants at full-term equivalent age (40 weeks post-menstrual age)). 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 NCT00883974, which also lists 1 linked publication.
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 29 Oct 2009.