Affective Bonding in Mothers and Their Premature Newborn
NCT ID: NCT03070158
Last Updated: 2020-02-07
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
UNKNOWN
NA
148 participants
INTERVENTIONAL
2017-05-01
2020-12-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Efficacy of Expressive Writing in Mothers of Preterm Infants
NCT03423914
The Effect Of Therapeutic Touch To Mothers With Preterm Babies
NCT04122417
Effects of Clustering Care on the Physiological Stability of Preterm Infants.
NCT03490721
Impact of Premature Childbirth on Parental Outcomes During Baby's NICU Stay and Beyond
NCT04118751
Study of Swaddling on Tactile Learning in Premature Infants
NCT04315428
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NON_RANDOMIZED
SEQUENTIAL
SUPPORTIVE_CARE
SINGLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Attachment Promotion Intervention
Mothers will receive the intervention which includes an education session about newborn care, training in multisensory stimulation with the intervention ATVV and two domiciliary visits to follow up the mother and her premature infant.
Attachment Promotion
Attachment Promotion consists of:
1. Education session about newborn and mother care.
2. Training in multisensory stimulation using the ATVV Intervention (auditory, tactile, visual and vestibular)
3. Two domiciliary visits to follow up and to give education about newborn care and ATVV Intervention.
4. Daily Phone follows up.
Usual Care
Mothers will continue to receive usual which consist in education session about newborn care in home.
No interventions assigned to this group
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Attachment Promotion
Attachment Promotion consists of:
1. Education session about newborn and mother care.
2. Training in multisensory stimulation using the ATVV Intervention (auditory, tactile, visual and vestibular)
3. Two domiciliary visits to follow up and to give education about newborn care and ATVV Intervention.
4. Daily Phone follows up.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Neonates who had been hospitalized in the neonatal care unit, with ages ranging from 29 - 36.6/7 weeks gestation at birth.
* Apgar to the minute and five minutes greater to 7/10
Mother:
* Mother with nursing diagnosis: Risk of impaired attachment.
* Mother with a neonate who had hospitalized in the neonatal care unit, with ages ranging from 29 - 36.6/7 weeks of gestation at birth
* Mother living in the metropolitan perimeter of the city of Bucaramanga
Exclusion Criteria
* Infants that underwent surgery
* Infants with neurological injury.
* Congenital cardiac abnormalities, severe deformities, grade III intraventricular hemorrhage.
Mother:
* Mother with limitations: hearing, motor and / or mental handicap-measured through the Abbreviated Mental Test (minimental), that prevent the intervention.
* Mother consuming psychoactive substances.
* With mental alterations, verified in the medical history.
29 Weeks
36 Weeks
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Universidad Industrial de Santander
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Beatriz Villamizar Carvajal
Principal Investigator
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Beatriz Villamizar- Carvajal, PhD
Role: PRINCIPAL_INVESTIGATOR
Universidad Industrial de Santander
Carolina Vargas- Porras, Msc
Role: STUDY_CHAIR
Universidad Industrial de Santander
Mayut Delgado-Galeano, Msc
Role: STUDY_CHAIR
Universidad Industrial de Santander
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Nursing School, Universidad Industrial de Santander
Bucaramanga, Santander Department, Colombia
Clinica Materno Infantil San Luis
Bucaramanga, Santander Department, Colombia
Hospital Universitario de Santander
Bucaramanga, Santander Department, Colombia
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
References
Explore related publications, articles, or registry entries linked to this study.
Femitha P, Bhat BV. Early neonatal outcome in late preterms. Indian J Pediatr. 2012 Aug;79(8):1019-24. doi: 10.1007/s12098-011-0620-9. Epub 2011 Dec 10.
Kelly MM. Comparison of functional status of 8- to 12-year-old children born prematurely: an integrative review of literature. J Pediatr Nurs. 2012 Aug;27(4):299-309. doi: 10.1016/j.pedn.2011.03.010. Epub 2011 May 11.
Pickler RH, McGrath JM, Reyna BA, McCain N, Lewis M, Cone S, Wetzel P, Best A. A model of neurodevelopmental risk and protection for preterm infants. J Perinat Neonatal Nurs. 2010 Oct-Dec;24(4):356-65. doi: 10.1097/JPN.0b013e3181fb1e70.
Howland LC, Pickler RH, McCain NL, Glaser D, Lewis M. Exploring biobehavioral outcomes in mothers of preterm infants. MCN Am J Matern Child Nurs. 2011 Mar-Apr;36(2):91-7. doi: 10.1097/NMC.0b013e318205587e.
Forcada-Guex M, Borghini A, Pierrehumbert B, Ansermet F, Muller-Nix C. Prematurity, maternal posttraumatic stress and consequences on the mother-infant relationship. Early Hum Dev. 2011 Jan;87(1):21-6. doi: 10.1016/j.earlhumdev.2010.09.006. Epub 2010 Oct 15.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
1900
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.