Very Low BirthweightNCT01385254
Mother Sibling Interactions Following Very Low Birth Weight (VLBW) Infant Homecoming
An observational study of Very Low Birthweight, run by Duke University at 2 sites in United States.
Trial summary
The proposed study will explore longitudinally the impact of a very low birthweight (VLBW) infant on mother-sibling interactions and sibling adjustment. The study will also include a comparison group of fullterm infants to determine which sibling adjustment problems are typical of having a new baby in the home and… Read more about this study
- Who is it for?
- Ages Up to 4 yearsHealthy volunteers can take part
- Conditions the study is for
- Very Low Birthweight
- How many people
- 300 participants
- Where
- 2 sitesUnited States
- Study dates
- Jan 2010to Oct 2012
- 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 4 years
- All sexes
- Healthy volunteers accepted
- Child
Study population: Mothers who give birth at Duke University Medical Center, Durham Regional Hospital, or Wake Medical Center, and their siblings.
Who may be able to join
- Siblings of very low birth weight or healthy, full-term infants
- age 4 years old or younger
- siblings and infants must live with the mother
- no previous or current diagnosis of major psychological disorder (including bipolar disorder, psychosis, or active substance abuse)
- age 18 years or older
- English speaking,
- living within 1 hour's travel distance from Duke University, for feasibility.
- Mothers at-risk for preterm birth who meet all other eligibility criteria
Who cannot join
- Mother/sibling pairs of infants who:
- have congenital neurological problems (congenital hydrocephalus or microcephaly),
- are symptomatic from substance exposure,
- are hospitalized longer than 1 month after term, or
- are technology dependent.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Duke University Medical Center
Durham, North Carolina, 27710
Wake Medical Center
Raleigh, North Carolina, 27610
About this study
The proposed study will explore longitudinally the impact of a very low birthweight (VLBW) infant on mother-sibling interactions and sibling adjustment. The study will also include a comparison group of fullterm infants to determine which sibling adjustment problems are typical of having a new baby in the home and which are associated with the unique stress of having a VLBW infant. This study will be the initial step in identifying factors affecting the adjustment of siblings of VLBW infants.
Read the detailed description
The proposed 2-year study will use a longitudinal, comparative, mixed method design to explore the impact of a Very Low Birth Weight (VLBW) (≤33 weeks gestational age) infant on mother-sibling interactions and sibling adjustment. A comparison group of full term infants (≥38 weeks gestational age) will be included to elucidate sibling adjustment problems that are typical to having a new baby in the home and sibling adjustment problems that are associated with the unique stress of having to care for a VLBW infant. Participants will be fifty mothers and siblings of VLBW infants and fifty mothers and siblings of full term infants. Data collection will take place within one week of infant discharge from the hospital (enrollment), and at 1 month and 6 months post infant discharge using self-report measures, qualitative interviews, and mother-sibling interaction observation. Variables of interest include mother's worry, anxiety, depression, and post-traumatic stress; mother-sibling interactions including uninvolvement, positive affect, negative affect, talk, looking and playing; internalizing and externalizing behaviors, sleep/somatic problems, and growth in siblings of VLBW and in siblings of the comparison group with full term infants. Mixed modeling and Ordinary Least Squares (OLS) regression modeling will be conducted to identify factors that make siblings vulnerable to psychological and emotional adjustment problems in response to having a VLBW infant in the home. There are no anticipated risks for the infant participants of the study aside from the small risk of violating confidentiality of infant participants and their mothers. No risks for siblings are anticipated aside from the small risk of violating confidentiality.
- Conditions
- Very Low Birthweight
- Keywords
- very low birthweight, premature, sibling adjustment, preterm
- Medical subject headings
- Premature Birth
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 |
|---|---|---|
| siblings and mothers of Very Low Birth Weight infants | 50 older siblings (closest in age) and mothers of very low birthweight (VLBW) infants, born at <33 weeks gestation and <1500 grams at birth | |
| siblings and mothers of healthy infants | 50 siblings (closest in age) and mothers of healthy, full-term infants (between 38-42 weeks gestation and lacking medical conditions that require a hospital stay past the mother's discharge date) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Differences in level of maternal worry in mothers of very low birthweight (VLBW) infants compared to mothers of full-term infants
Explore how the trajectories of maternal worry about the infant and sibling, anxiety, depression, post traumatic stress, concerns for and expectations of the sibling, and perceptions of sibling growth over the 6-month post discharge period differ between mothers of VLBW infants and mothers of fullterms.
Measured: baseline, one month, six months
Differences in mother-sibling interaction between two groups
Explore differences in mother-sibling interactions, including involvement, positive/negative affect, talking, looking and playing, at 1 and 6 months after infant discharge between the two groups of siblings and mothers, using a coding schema to score videotaped interactions.
Measured: one month and six months
Differences in internalizing and externalizing behaviors between two groups
Explore differences in internalizing and externalizing behaviors, vulnerability, and sleep/somatic problems at 6-months post-infant discharge between siblings of VLBW infants and siblings of fullterms, using a coding schema to score videotaped interactions.
Measured: one month and six months
Secondary outcomes (2)
Effects of maternal worry, anxiety, depression and Post-Traumatic Stress Disorder (PTSD) on two groups
Examine the effects of maternal worry, anxiety, depression, and post traumatic stress on group differences in mother-sibling interactions at 1 and 6 months after infant discharge.
Measured: one month and six months
Change in mother-sibling interactions between groups
Examine the effects of changes in mother-sibling interactions from 1 to 6 months after infant discharge on group differences in siblings' internalizing and externalizing behaviors, vulnerability, and sleep/somatic problems.
Measured: one month and six months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jun 2011 (estimated)
- Study startJan 2010
- Primary completionMay 2012
- Study completionOct 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Very Low BirthweightStudies of the same condition, open and under way.
- More trials run by Duke UniversityThe 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 300 participants (actual)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Nursing Research (NINR)
- Responsible party
- Sponsor
- Investigators
- Julie A Thompson, PhD, Principal investigator, Duke University School of Nursing
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01385254
- Sponsor's protocol ID
- Pro00019788
- Other IDs
- 1R03NR011196-01A1
- Status last verified
- Dec 2013
- First submitted
- 20 Jan 2011
- Last updated
- 11 Dec 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 11 Dec 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mother Sibling Interactions Following Very Low Birth Weight (VLBW) Infant Homecoming
- ClinicalTrials.gov ID
- NCT01385254
- Acronym / sponsor ID
- Pro00019788
- Conditions
- Very Low Birthweight
- Keywords
- very low birthweight, premature, sibling adjustment, preterm
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 300 participants (actual)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Collaborators
- National Institute of Nursing Research (NINR)
- Study start
- Jan 2010
- Primary completion
- May 2012 (actual)
- Study completion
- Oct 2012 (actual)
- First posted
- 30 Jun 2011 (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 proposed study will explore longitudinally the impact of a very low birthweight (VLBW) infant on mother-sibling interactions and sibling adjustment. The study will also include a comparison group of fullterm infants to determine which sibling adjustment problems are typical of having a new baby in the home and which are associated with the unique stress of having a VLBW infant. This study will be the initial step in identifying factors affecting the adjustment of siblings of VLBW infants.
Detailed description
The proposed 2-year study will use a longitudinal, comparative, mixed method design to explore the impact of a Very Low Birth Weight (VLBW) (≤33 weeks gestational age) infant on mother-sibling interactions and sibling adjustment. A comparison group of full term infants (≥38 weeks gestational age) will be included to elucidate sibling adjustment problems that are typical to having a new baby in the home and sibling adjustment problems that are associated with the unique stress of having to care for a VLBW infant. Participants will be fifty mothers and siblings of VLBW infants and fifty mothers and siblings of full term infants. Data collection will take place within one week of infant discharge from the hospital (enrollment), and at 1 month and 6 months post infant discharge using self-report measures, qualitative interviews, and mother-sibling interaction observation. Variables of interest include mother's worry, anxiety, depression, and post-traumatic stress; mother-sibling interactions including uninvolvement, positive affect, negative affect, talk, looking and playing; internalizing and externalizing behaviors, sleep/somatic problems, and growth in siblings of VLBW and in siblings of the comparison group with full term infants. Mixed modeling and Ordinary Least Squares (OLS) regression modeling will be conducted to identify factors that make siblings vulnerable to psychological and emotional adjustment problems in response to having a VLBW infant in the home. There are no anticipated risks for the infant participants of the study aside from the small risk of violating confidentiality of infant participants and their mothers. No risks for siblings are anticipated aside from the small risk of violating confidentiality.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| siblings and mothers of Very Low Birth Weight infants | – | –50 older siblings (closest in age) and mothers of very low birthweight (VLBW) infants, born at <33 weeks gestation and <1500 grams at birth |
| siblings and mothers of healthy infants | – | –50 siblings (closest in age) and mothers of healthy, full-term infants (between 38-42 weeks gestation and lacking medical conditions that require a hospital stay past the mother's discharge date) |
Who may qualify
- Ages
- Up to 4 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- Mothers who give birth at Duke University Medical Center, Durham Regional Hospital, or Wake Medical Center, and their siblings.
Key inclusion criteria (8 listed)
- Siblings of very low birth weight or healthy, full-term infants
- age 4 years old or younger
- siblings and infants must live with the mother
- no previous or current diagnosis of major psychological disorder (including bipolar disorder, psychosis, or active substance abuse)
- age 18 years or older
Key exclusion criteria (5 listed)
- have congenital neurological problems (congenital hydrocephalus or microcephaly),
- are symptomatic from substance exposure,
- are hospitalized longer than 1 month after term, or
- are technology dependent.
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
Differences in level of maternal worry in mothers of very low birthweight (VLBW) infants compared to mothers of full-term infants
Time frame: baseline, one month, six months
Explore how the trajectories of maternal worry about the infant and sibling, anxiety, depression, post traumatic stress, concerns for and expectations of the sibling, and perceptions of sibling growth over the 6-month post discharge period differ between mothers of VLBW infants and mothers of fullterms.
Differences in mother-sibling interaction between two groups
Time frame: one month and six months
Explore differences in mother-sibling interactions, including involvement, positive/negative affect, talking, looking and playing, at 1 and 6 months after infant discharge between the two groups of siblings and mothers, using a coding schema to score videotaped interactions.
Differences in internalizing and externalizing behaviors between two groups
Time frame: one month and six months
Explore differences in internalizing and externalizing behaviors, vulnerability, and sleep/somatic problems at 6-months post-infant discharge between siblings of VLBW infants and siblings of fullterms, using a coding schema to score videotaped interactions.
2 secondary outcomes
Effects of maternal worry, anxiety, depression and Post-Traumatic Stress Disorder (PTSD) on two groups
Time frame: one month and six months
Change in mother-sibling interactions between groups
Time frame: one month and six months
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 11 Dec 2013.
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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.
Julie A Thompson, PhD principal investigator
Duke University School of Nursing
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Very Low Birthweight, run by Duke University 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 8 inclusion and 5 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 11 Dec 2013. 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.
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?
Differences in level of maternal worry in mothers of very low birthweight (VLBW) infants compared to mothers of full-term infants (time frame: baseline, one month, six months). 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?
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 11 Dec 2013.