Preterm BirthPhase 2NCT00166660
Preterm Fetal Growth Restriction and Developmental Care
A Phase 2 study testing NIDCAP (Newborn Individualized Developmental Care) in people with Preterm Birth, run by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) at 2 sites in United States.
Trial summary
The goal of the project is to show the effectiveness of individualized developmental care and intervention, which begins with the FGR preterm infant's admission to the newborn intensive care unit (NICU) and extends to 2 weeks (w) after full term equivalent age or 2w CA (corrected age for prematurity). Read more about this study
- Who is it for?
- Ages 28 to 33 weeks
- Conditions the study is for
- Preterm Birth
- What is being tested?
- NIDCAP (Newborn Individualized Developmental Care)
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 30 participants
- Where
- 2 sitesUnited States
- Study dates
- Jul 2004to Jun 2009
- Phase
- Phase 2
- 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 28 to 33 weeks
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Inborn at Brigham and Women's Hospital, Boston
- Gestational age ≥28 and ≤33 weeks
- Doppler diagnosed absent or reversed end-diastolic umbilical artery flow velocity
- Less than 5th percentile in birthweight and head circumference for gestational age
Who cannot join
- Major chromosomal or congenital anomalies
- Major congenital infections
- Significant prenatal diagnosed focal brain lesions
- Uncontrolled maternal illness
- History of smoking, alcoholism, and use of illicit drugs
- History of significant maternal deprivation, abuse, or malnutrition
- No telephone access and/or insufficient English language facility
Trial locations and contacts
2 sites in 1 country.
United States2 sites, 2 recruiting
- Recruiting
Brigham and Women's Hospital
Boston, Massachusetts, 02115
Heidelise Als, PhD, 617-355-8249, heidelise.als@childrens.harvard.edu
Simon Warfield, PhD
- Recruiting
Children's Hospital Boston
Boston, Massachusetts, 02115
Heidelise Als, PhD, 617-355-8249, heidelise.als@childrens.harvard.edu
About this study
The goal of the project is to show the effectiveness of individualized developmental care and intervention, which begins with the FGR preterm infant's admission to the newborn intensive care unit (NICU) and extends to 2 weeks (w) after full term equivalent age or 2w CA (corrected age for prematurity).
Read the detailed description
The protocol aims to demonstrate the effectiveness of an intervention geared to significantly improve functional competence for preterm infants with fetal growth restriction (FGR). Incidence of FGR is estimated to be as high as 5% of the general obstetric population. Preterms with FGR are doubly jeopardized. Aside from much higher mortality rates they also show significantly increased morbidity rates, including significant learning disabilities and school failure (>50%). The intervention's underlying premise holds that it is far more effective to support the immature brain, which is compromised by FGR, to develop optimally before the infant reaches full term rather than to attempt to ameliorate increasingly deviant development after deviance has occurred. The goal of the project is to show the effectiveness of individualized developmental care and intervention, which begins with the FGR preterm infant's admission to the newborn intensive care unit (NICU) and extends to 2 weeks (w) after full term equivalent age or 2w CA (corrected age for prematurity). Intervention in the NICU is considered more advantageous for the infant's later development than delay of intervention until after discharge home. The proposal maintains that the last trimester of gestation is a critical period for brain development, especially when compromised by FGR. In-NICU intervention at this critical brain development time is expected to reduce the infants' hypersensitivity and reactivity while in the NICU, and to lead to reduction of the high incidence of behavioral problems in infancy, which frequently foreshadows later behavioral and learning problems as well as school failure.
The study aims to test three related hypotheses:
- Individualized developmental NICU care and intervention will enhance FGR preterm infants' brain development both functionally and structurally.
- The in-NICU intervention will improve the parents' understanding of their infant's individuality and equip them to feel more competent as parents.
- The intervention itself, while individualized for each infant, will be quantifiable and reliably reproducible.
The study will:
- Test the effectiveness of the intervention by assessing brain development and functional adaptation of a high risk preterm population (n=30) with documented intrauterine FGR and born between 28 and 33w gestational age.
- Assess the FGR preterm infants' neurodevelopment within one week from birth (baseline) and again at 2w CA (outcome).
- Compare the results on the effectiveness of the intervention for the FGR preterm infants to a recently studied cohort of appropriately grown (AGA) preterm infants born at comparable gestational ages, supported with the same intervention and measured in comparable ways.
The primary infant measures proposed will be brain functional (EEG coherence, neurobehavioral functioning) and brain structural assessments (MRI). The goal will be to examine the direct causal connections and correlations among population characteristics, the intervention, and ultimate outcome at 2w CA. The project is expected to deliver comprehensive and substantive results in favor of the developmental NICU intervention for FGR preterm infants as well as for the earlier studied AGA population. The proposed study is expected to demonstrate intervention effectiveness in improving FGR preterm infants' neurodevelopment. It is anticipated that the intervention-based improvement in brain structure and function will set the stage for improvement in later performance, especially in terms of behavioral/emotional adaptation, learning and school achievement, which are all critical for life success.
- Conditions
- Preterm Birth
- Being tested
- NIDCAP (Newborn Individualized Developmental Care)
- Keywords
- Preterm infants, Developmental Care, NIDCAP, Fetal Growth Restriction, Neurobehavior, APIB, MRI, EEG, Parent Stress
- Medical subject headings
- Premature Birth, Fetal Growth Retardation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NIDCAP (Newborn Individualized Developmental Care)Behavioural
The NIDCAP model aims to create a relationship-based developmentally supportive care environment for the preterm infant and family. The theory proposes that care implementation that takes into account the infants' thresholds of disorganization is most supportive of long term outcome. Specifically, the intervention consisted of weekly neurobehavioral observations and reports of the experimental group infants' behavior with suggestions for parents and staff in ways to support each infant's development. The developmental specialists formally observed each infant's behavior weekly throughout the hospitalization, starting with the phase of the infant's initial stabilization, and then every seven days throughout hospital discharge and to 2wCA.
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of Preterm Infants' Behavior (APIB)
Measured: 2 weeks corrected age (2w CA)
Quantified Electroencephalography (qEEG)
Measured: 2 weeks Corrected Age (2w CA)
Magnetic Resonance Imaging(MRI)
Measured: 2 weeks Corrected Age (2w CA)
Secondary outcomes (1)
Parent Stress Level
Measured: 2 weeks Corrected Age (2w CA)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2005 (estimated)
- Study startJul 2004
- Primary completionDec 2008 (estimated)
- Study completionJun 2009 (estimated)
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 Preterm BirthStudies 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 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Sponsor type
- US National Institutes of Health
- Investigators
- Heidelise Als, PhD, Principal investigator, Boston Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00166660
- Sponsor's protocol ID
- R01HD046855
- Status last verified
- Mar 2009
- First submitted
- 9 Sep 2005
- Last updated
- 3 Apr 2009
- Results posted
- No
- Data monitoring committee
- No
Publications
Als H, Duffy FH, McAnulty GB, Rivkin MJ, Vajapeyam S, Mulkern RV, Warfield SK, Huppi PS, Butler SC, Conneman N, Fischer C, Eichenwald EC. Early experience alters brain function and structure. Pediatrics. 2004 Apr;113(4):846-57. doi: 10.1542/peds.113.4.846.
PubMed 15060237
Study at a glance
From the registry record, last updated by the sponsor on 3 Apr 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preterm Fetal Growth Restriction and Developmental Care
- ClinicalTrials.gov ID
- NCT00166660
- Acronym / sponsor ID
- R01HD046855
- Conditions
- Preterm Birth
- Keywords
- Preterm infants, Developmental Care, NIDCAP, Fetal Growth Restriction, Neurobehavior, APIB, MRI, EEG
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)US National Institutes of Health
- Study start
- Jul 2004
- Primary completion
- Dec 2008 (estimated)
- Study completion
- Jun 2009 (estimated)
- First posted
- 14 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 goal of the project is to show the effectiveness of individualized developmental care and intervention, which begins with the FGR preterm infant's admission to the newborn intensive care unit (NICU) and extends to 2 weeks (w) after full term equivalent age or 2w CA (corrected age for prematurity).
Detailed description
The protocol aims to demonstrate the effectiveness of an intervention geared to significantly improve functional competence for preterm infants with fetal growth restriction (FGR). Incidence of FGR is estimated to be as high as 5% of the general obstetric population. Preterms with FGR are doubly jeopardized. Aside from much higher mortality rates they also show significantly increased morbidity rates, including significant learning disabilities and school failure (>50%). The intervention's underlying premise holds that it is far more effective to support the immature brain, which is compromised by FGR, to develop optimally before the infant reaches full term rather than to attempt to ameliorate increasingly deviant development after deviance has occurred. The goal of the project is to show the effectiveness of individualized developmental care and intervention, which begins with the FGR preterm infant's admission to the newborn intensive care unit (NICU) and extends to 2 weeks (w) after full term equivalent age or 2w CA (corrected age for prematurity). Intervention in the NICU is considered more advantageous for the infant's later development than delay of intervention until after discharge home. The proposal maintains that the last trimester of gestation is a critical period for brain development, especially when compromised by FGR. In-NICU intervention at this critical brain development time is expected to reduce the infants' hypersensitivity and reactivity while in the NICU, and to lead to reduction of the high incidence of behavioral problems in infancy, which frequently foreshadows later behavioral and learning problems as well as school failure.
The study aims to test three related hypotheses:
- Individualized developmental NICU care and intervention will enhance FGR preterm infants' brain development both functionally and structurally.
- The in-NICU intervention will improve the parents' understanding of their infant's individuality and equip them to feel more competent as parents.
- The intervention itself, while individualized for each infant, will be quantifiable and reliably reproducible.
The study will:
- Test the effectiveness of the intervention by assessing brain development and functional adaptation of a high risk preterm population (n=30) with documented intrauterine FGR and born between 28 and 33w gestational age.
- Assess the FGR preterm infants' neurodevelopment within one week from birth (baseline) and again at 2w CA (outcome).
- Compare the results on the effectiveness of the intervention for the FGR preterm infants to a recently studied cohort of appropriately grown (AGA) preterm infants born at comparable gestational ages, supported with the same intervention and measured in comparable ways.
The primary infant measures proposed will be brain functional (EEG coherence, neurobehavioral functioning) and brain structural assessments (MRI). The goal will be to examine the direct causal connections and correlations among population characteristics, the intervention, and ultimate outcome at 2w CA. The project is expected to deliver comprehensive and substantive results in favor of the developmental NICU intervention for FGR preterm infants as well as for the earlier studied AGA population. The proposed study is expected to demonstrate intervention effectiveness in improving FGR preterm infants' neurodevelopment. It is anticipated that the intervention-based improvement in brain structure and function will set the stage for improvement in later performance, especially in terms of behavioral/emotional adaptation, learning and school achievement, which are all critical for life success.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
Who may qualify
- Ages
- 28 to 33 weeks
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Inborn at Brigham and Women's Hospital, Boston
- Gestational age ≥28 and ≤33 weeks
- Doppler diagnosed absent or reversed end-diastolic umbilical artery flow velocity
- Less than 5th percentile in birthweight and head circumference for gestational age
Key exclusion criteria (7 listed)
- Major chromosomal or congenital anomalies
- Major congenital infections
- Significant prenatal diagnosed focal brain lesions
- Uncontrolled maternal illness
- History of smoking, alcoholism, and use of illicit drugs
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 |
|---|---|---|
| NIDCAP (Newborn Individualized Developmental Care)The NIDCAP model aims to create a relationship-based developmentally supportive care environment for the preterm infant and family. The theory proposes that care implementation that takes into account the infants' thresholds of disorganization is most supportive of long term outcome. Specifically, the intervention consisted of weekly neurobehavioral observations and reports of the experimental group infants' behavior with suggestions for parents and staff in ways to support each infant's development. The developmental specialists formally observed each infant's behavior weekly throughout the hospitalization, starting with the phase of the infant's initial stabilization, and then every seven days throughout hospital discharge and to 2wCA. | Behavioural | – |
Primary outcome
Assessment of Preterm Infants' Behavior (APIB)
Time frame: 2 weeks corrected age (2w CA)
Quantified Electroencephalography (qEEG)
Time frame: 2 weeks Corrected Age (2w CA)
Magnetic Resonance Imaging(MRI)
Time frame: 2 weeks Corrected Age (2w CA)
1 secondary outcome
Parent Stress Level
Time frame: 2 weeks Corrected Age (2w CA)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Apr 2009.
- Background: PubMed 15060237Als H, Duffy FH, McAnulty GB, Rivkin MJ, Vajapeyam S, Mulkern RV, Warfield SK, Huppi PS, Butler SC, Conneman N, Fischer C, Eichenwald EC. Early experience alters brain function and structure. Pediatrics. 2004 Apr;113(4):846-57. doi: 10.1542/peds.113.4.846.
Related trials for Preterm Birth
Not yet recruitingObservational study
Effect of Antenatal Dexamethasone on Postnatal Adrenal Hormones in Preterm Neonates
Preterm Birth Infants
RecruitingPhase 3
Preeclampsia Intervention Netherlands
Pre-Eclampsia Onset Less Than 37 Weeks, Pre-Eclampsia
Not yet recruiting
Eye Covering and White Noise During Nasogastric Tube Insertion in Preterm Infants
Preterm Infants
Recruiting
Protocol-driven Nutrition in Preterm Infants
Preterm Infants
Recruiting
Controlled Remote Monitoring and Optimization of Oxygen Therapy in Preterm Infants
BPD - Bronchopulmonary Dysplasia, Pulmonary Hypertension
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.
Heidelise Als, PhD principal investigator
Boston Children's Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing NIDCAP (Newborn Individualized Developmental Care) in people with Preterm Birth, run by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) at 2 sites in United States.
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 4 inclusion and 7 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: status not confirmed, as of the sponsor's last update on 3 Apr 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 United States. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Heidelise Als, PhD (617-355-8249, heidelise.Als@childrens.harvard.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assessment of Preterm Infants' Behavior (APIB) (time frame: 2 weeks corrected age (2w CA)). The study lists 3 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 NCT00166660, 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 3 Apr 2009.