HealthyNCT00053469
Infant s Examination and Manipulation of Objects
An observational study of Healthy and Infant, run by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) at 1 site in United States.
Trial summary
This study will explore how babies become able to use their experience with objects to plan to manipulate them appropriately. For example, an adult knows that picking up a grocery bag full of canned food requires different actions than are needed for lifting an empty bag. Read more about this study
- Who is it for?
- Ages Up to 2 years
- How many people
- 350 participants
- Where
- 1 siteUnited States
- Study dates
- 28 Jan 2003to 30 Mar 2015
- 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 Up to 2 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Infants will be selected for inclusion in each study on the basis of age, gestational status (i.e., full-term vs. pre-term birth), visual normality, and general health status.
- The initial group will be recruited to participate within two weeks on either side of their first birthday (12 months of age).
- Equal numbers of males and females will be recruited to participate. If the sample participating in either experiment fails to perform in the manner expected, additional participants will be recruited at older test ages to identify when in the course of development such behavioral guidance emerges. As successive test ages will be separated by 6 month intervals, independent samples of 18-, then 24-month-old children will be recruited until the expected pattern of adaptive actions is observed (cf. Fossberg, et al., 1992).
Who cannot join
- Infants with a gestational age of less than 36 weeks, and/or those with histories of severe perinatal complications, visual abnormalities, or congenital developmental disorders will not be recruited for participation.
Trial locations and contacts
1 site in 1 country.
United States1 site
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, 20892
About this study
Official title: Early Learning and Development Project
This study will explore how babies become able to use their experience with objects to plan to manipulate them appropriately. For example, an adult knows that picking up a grocery bag full of canned food requires different actions than are needed for lifting an empty bag. This study will examine when and how infants first begin to adapt their actions to manipulate specific objects that weigh different amounts.
Participants will include normal healthy babies within 2 weeks of their first birthday. If the expected results are obtained from testing, 9-month-old children will then be studied to identify a lower age boundary in task performance. If the expected results are not obtained at the 12-month test age, older children will be recruited to participate.
Read more
The study involves one 30-minute session with the baby and his or her mother or father. The parent will answer some questions about the family, such as its size and ethnic make-up. The infant will then have small magnetic sensors taped to the underside of each arm and to the back. While sitting on the parent s lap, the infant will be presented with plastic toys, and his or her actions will be measured by the sensors as he or she reaches for and picks up the toys. The sensors will be connected to a computer that will track and record the motion of the infant s arms.
...
Read the detailed description
The major objective of this research is to better understand the functional significance of object categorization in early development. The proposed work is designed to examine the emergence of infants ability to access internal categorical representations in service of planning actions on the external environment. Representation, in this capacity, refers simply to stored information that can influence later behavior. Categorization refers to the treatment of discriminable objects as equivalent in some way. Even very young infants appear able to visually categorize diverse sets of discriminable patterns or objects, and can form internal representations of such bounded collections. Much less is known, however, about infants ability to actually utilize such representations in the guidance of goal directed action. The present research is designed to characterize the functional and behavioral significance of object representations in infancy, focusing particularly on categorically organized representations. The primary research strategy to be used consists of analyzing infants examination and manipulation of novel objects that vary both in visual (i.e., shape and color) as well as nonvisual dimensions (i.e., weight). In a laboratory procedure, twelve-month old infants will explore novel objects of different weights, and their subsequent handling of modified test objects will be measured with an electronic motion analysis system. Kinematic analyses of infants actions on the test objects will reveal how these actions were prepared in relation to their previous experience with similar objects.
- Keywords
- Cognitive Development, Motor Planning, Categorization, Perception, Adaptation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2003 (estimated)
- Study start28 Jan 2003
- Study completion30 Mar 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for HealthyStudies 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
- Observational
- Enrolment
- 350 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Clay W. Mash, Ph.D., Principal investigator, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00053469
- Sponsor's protocol ID
- 030069
- Other IDs
- 03-CH-0069
- Status last verified
- 30 Mar 2015
- First submitted
- 30 Jan 2003
- Last updated
- 17 Dec 2019
- Results posted
- No
Publications
Adolph KE. Learning in the development of infant locomotion. Monogr Soc Res Child Dev. 1997;62(3):I-VI, 1-158.
PubMed 9394468Baillargeon R. Representing the existence and the location of hidden objects: object permanence in 6- and 8-month-old infants. Cognition. 1986 Jun;23(1):21-41. doi: 10.1016/0010-0277(86)90052-1. No abstract available.
PubMed 3742989Bornstein MH, Kessen W, Weiskopf S. Color vision and hue categorization in young human infants. J Exp Psychol Hum Percept Perform. 1976 Feb;2(1):115-29. doi: 10.1037//0096-1523.2.1.115.
PubMed 1262792
Study at a glance
From the registry record, last updated by the sponsor on 17 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Learning and Development Project
- ClinicalTrials.gov ID
- NCT00053469
- Acronym / sponsor ID
- 030069
- Keywords
- Cognitive Development, Motor Planning, Categorization, Perception, Adaptation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 350 participants (actual)
- Lead sponsor
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)US National Institutes of Health
- Study start
- 28 Jan 2003
- Study completion
- 30 Mar 2015
- First posted
- 30 Jan 2003 (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.
This study will explore how babies become able to use their experience with objects to plan to manipulate them appropriately. For example, an adult knows that picking up a grocery bag full of canned food requires different actions than are needed for lifting an empty bag. This study will examine when and how infants first begin to adapt their actions to manipulate specific objects that weigh different amounts.
Participants will include normal healthy babies within 2 weeks of their first birthday. If the expected results are obtained from testing, 9-month-old children will then be studied to identify a lower age boundary in task performance. If the expected results are not obtained at the 12-month test age, older children will be recruited to participate.
The study involves one 30-minute session with the baby and his or her mother or father. The parent will answer some questions about the family, such as its size and ethnic make-up. The infant will then have small magnetic sensors taped to the underside of each arm and to the back. While sitting on the parent s lap, the infant will be presented with plastic toys, and his or her actions will be measured by the sensors as he or she reaches for and picks up the toys. The sensors will be connected to a computer that will track and record the motion of the infant s arms.
...
Detailed description
The major objective of this research is to better understand the functional significance of object categorization in early development. The proposed work is designed to examine the emergence of infants ability to access internal categorical representations in service of planning actions on the external environment. Representation, in this capacity, refers simply to stored information that can influence later behavior. Categorization refers to the treatment of discriminable objects as equivalent in some way. Even very young infants appear able to visually categorize diverse sets of discriminable patterns or objects, and can form internal representations of such bounded collections. Much less is known, however, about infants ability to actually utilize such representations in the guidance of goal directed action. The present research is designed to characterize the functional and behavioral significance of object representations in infancy, focusing particularly on categorically organized representations. The primary research strategy to be used consists of analyzing infants examination and manipulation of novel objects that vary both in visual (i.e., shape and color) as well as nonvisual dimensions (i.e., weight). In a laboratory procedure, twelve-month old infants will explore novel objects of different weights, and their subsequent handling of modified test objects will be measured with an electronic motion analysis system. Kinematic analyses of infants actions on the test objects will reveal how these actions were prepared in relation to their previous experience with similar objects.
Study design
Who may qualify
- Ages
- Up to 2 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Infants will be selected for inclusion in each study on the basis of age, gestational status (i.e., full-term vs. pre-term birth), visual normality, and general health status.
- The initial group will be recruited to participate within two weeks on either side of their first birthday (12 months of age).
- Equal numbers of males and females will be recruited to participate. If the sample participating in either experiment fails to perform in the manner expected, additional participants will be recruited at older test ages to identify when in the course of development such behavioral guidance emerges. As successive test ages will be separated by 6 month intervals, independent samples of 18-, then 24-month-old children will be recruited until the expected pattern of adaptive actions is observed (cf. Fossberg, et al., 1992).
Key exclusion criteria (1 listed)
- Infants with a gestational age of less than 36 weeks, and/or those with histories of severe perinatal complications, visual abnormalities, or congenital developmental disorders will not be recruited for participation.
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
Not reported in the source record.
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 17 Dec 2019.
- Background: PubMed 9394468Adolph KE. Learning in the development of infant locomotion. Monogr Soc Res Child Dev. 1997;62(3):I-VI, 1-158.
- Background: PubMed 3742989Baillargeon R. Representing the existence and the location of hidden objects: object permanence in 6- and 8-month-old infants. Cognition. 1986 Jun;23(1):21-41. doi: 10.1016/0010-0277(86)90052-1. No abstract available.
- Background: PubMed 1262792Bornstein MH, Kessen W, Weiskopf S. Color vision and hue categorization in young human infants. J Exp Psychol Hum Percept Perform. 1976 Feb;2(1):115-29. doi: 10.1037//0096-1523.2.1.115.
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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.
Clay W. Mash, Ph.D. principal investigator
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
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 Healthy and Infant, run by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) at 1 site 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 3 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: finished, as of the sponsor's last update on 17 Dec 2019. 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 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.
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.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00053469, which also lists 3 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 17 Dec 2019.