Preterm InfantsNCT00917475
Socio-Emotional Development in Preterm Infants
An observational study of Preterm Infants, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial summary
With advances in medicine and medical technology, premature infants born as early as 24 weeks of gestation and with birth weight less than 1000 grams are surviving today. Preterms are born with immature biological systems. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Preterm Infants
- How many people
- 100 participants
- Where
- 1 siteTaiwan
- Study dates
- Jan 2010to Dec 2011
- Phase
- Observational
- 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
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Infants born prematurely with no significant congenital problems (e.g., cleft palate, cardiac malformations) and their mothers ages 18 to 40.
Who may be able to join
- preterm infants
Who cannot join
- significant congenital problems
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
National Taiwan University Hospital
Taipei, 100
Suh-Fang Jeng, Ph.D., (02)33668132, jeng@ntu.edu.tw
Hui-Chin Hsu, Ph.D.
About this study
With advances in medicine and medical technology, premature infants born as early as 24 weeks of gestation and with birth weight less than 1000 grams are surviving today. Preterms are born with immature biological systems. Given their biological vulnerabilities, preterm infants are at risk for a variety of health and developmental problems.
As a group, preterms show developmental delays in physical growth, motor skills, attention, social communicative skills, intelligence, language, academic performance, and later behavior problems. Furthermore, research indicates that preterms are difficult social partners for their parents.
Read more
Despite biological insults and relational difficulties, research also shows that the development of premature infants appears to be facilitated by sensitive and responsive parenting. Little attention, however, has been paid to understand the social risks faced by preterm infants.
The proposed research, therefore, is designed to:
- understand the extent to which neurophysiological risk may affect preterm infants' socioemotional development,
- explore the role of maternal social support, sociopsychological stress, and perception of infant vulnerability in the socioemotional development of preterm infants varying in biological risk,
- examine the role of social support in buffering stress in mothers of preterm infants, and
- evaluate the role of maternal stress, coping, and support in preterm infants' socioemotional development.
This study will include preterm infants recruited from the National Taiwan University Hospital at term and 12 months of corrected age. Infants will be examined for physical growth, neurobehavioral development, and mother and infant interaction at term. The growth measures including weight, height and head circumference will be assessed. Interaction between mother and infant will be investigated by observing the interaction between infants and their mothers in feeding and skin to skin contact conditions. Mothers' psychosocial stress and social support will be obtained via questionnaires.
It is expected that preterm infants' physical growth and neurobehavioral development as well as mothers' psychosocial stress and social support are associated with the quality of mother-infant interaction.
- Conditions
- Preterm Infants
- Keywords
- preterm infants
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Preterm infants | birth weight<1500 grams and gestational age<30 weeks |
What is being measured
The primary outcome is the main question the study is designed to answer.
quality of mother-infant interaction
Measured: term age and 12 months of corrected age
Secondary outcomes (1)
maternal parenting efficacy
Measured: term age and 12 months of corrected age
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jun 2009 (estimated)
- Study startJan 2010
- Primary completionDec 2010 (estimated)
- Study completionDec 2011 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Preterm InfantsStudies of the same condition, open and under way.
- More trials run by National Taiwan University HospitalThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- University of Georgia
- Investigators
- Hui-Chin Hsu, Ph.D., Principal investigator, University of Georgia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00917475
- Sponsor's protocol ID
- 200904054R
- Status last verified
- Jan 2010
- First submitted
- 8 Jun 2009
- Last updated
- 29 Jan 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jan 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Socio-Emotional Development in Preterm Infants
- ClinicalTrials.gov ID
- NCT00917475
- Acronym / sponsor ID
- 200904054R
- Conditions
- Preterm Infants
- Keywords
- preterm infants
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Collaborators
- University of Georgia
- Study start
- Jan 2010
- Primary completion
- Dec 2010 (estimated)
- Study completion
- Dec 2011 (estimated)
- First posted
- 10 Jun 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.
With advances in medicine and medical technology, premature infants born as early as 24 weeks of gestation and with birth weight less than 1000 grams are surviving today. Preterms are born with immature biological systems. Given their biological vulnerabilities, preterm infants are at risk for a variety of health and developmental problems.
As a group, preterms show developmental delays in physical growth, motor skills, attention, social communicative skills, intelligence, language, academic performance, and later behavior problems. Furthermore, research indicates that preterms are difficult social partners for their parents.
Despite biological insults and relational difficulties, research also shows that the development of premature infants appears to be facilitated by sensitive and responsive parenting. Little attention, however, has been paid to understand the social risks faced by preterm infants.
The proposed research, therefore, is designed to:
- understand the extent to which neurophysiological risk may affect preterm infants' socioemotional development,
- explore the role of maternal social support, sociopsychological stress, and perception of infant vulnerability in the socioemotional development of preterm infants varying in biological risk,
- examine the role of social support in buffering stress in mothers of preterm infants, and
- evaluate the role of maternal stress, coping, and support in preterm infants' socioemotional development.
This study will include preterm infants recruited from the National Taiwan University Hospital at term and 12 months of corrected age. Infants will be examined for physical growth, neurobehavioral development, and mother and infant interaction at term. The growth measures including weight, height and head circumference will be assessed. Interaction between mother and infant will be investigated by observing the interaction between infants and their mothers in feeding and skin to skin contact conditions. Mothers' psychosocial stress and social support will be obtained via questionnaires.
It is expected that preterm infants' physical growth and neurobehavioral development as well as mothers' psychosocial stress and social support are associated with the quality of mother-infant interaction.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Preterm infants | – | –birth weight<1500 grams and gestational age<30 weeks |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Infants born prematurely with no significant congenital problems (e.g., cleft palate, cardiac malformations) and their mothers ages 18 to 40.
Key inclusion criteria (1 listed)
- preterm infants
Key exclusion criteria (1 listed)
- significant congenital problems
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
quality of mother-infant interaction
Time frame: term age and 12 months of corrected age
1 secondary outcome
maternal parenting efficacy
Time frame: term age and 12 months of corrected age
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jan 2010.
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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.
Hui-Chin Hsu, Ph.D. principal investigator
University of Georgia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Preterm Infants, run by National Taiwan University Hospital at 1 site in Taiwan.
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 1 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 29 Jan 2010. 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 Taiwan. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Suh-Fang Jeng, Ph.D. ((02)33668132, jeng@ntu.edu.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
quality of mother-infant interaction (time frame: term age and 12 months of corrected age). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 Jan 2010.