Back to resultsAffective Bonding in Mothers and Their Premature Newborn
Primary Purpose
Premature Infant
Status
Unknown status
Phase
Not Applicable
Locations
Colombia
Study Type
Interventional
Intervention
Attachment Promotion
Sponsored by
About this trial
This is an interventional supportive care trial for Premature Infant focused on measuring Premature Infant, Mother-Infant Interaction, Acoustic stimulation/methods, Touch, Visual Stimulation, Vestibule, Labyrinth/physiology
Eligibility Criteria
Inclusion Criteria:
Premature Infant:
- 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:
Newborn:
- 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.
Sites / Locations
- Nursing School, Universidad Industrial de SantanderRecruiting
- Clinica Materno Infantil San LuisRecruiting
- Hospital Universitario de SantanderRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Attachment Promotion Intervention
Usual Care
Arm Description
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.
Mothers will continue to receive usual which consist in education session about newborn care in home.
Outcomes
Primary Outcome Measures
Affective bonding score
Changes in the mean score of the nursing outcome: affective bonding measure with the NOC(Nursing Outcomes Classification)
Secondary Outcome Measures
Coping adaptation score
Changes in the mean score of the coping measure with the Coping adaptation Processing Scale Abbreviated (CAPS Abbreviated - Spanish)
Full Information
NCT ID
NCT03070158
First Posted
February 28, 2017
Last Updated
February 6, 2020
Sponsor
Universidad Industrial de Santander
1. Study Identification
Unique Protocol Identification Number
NCT03070158
Brief Title
Affective Bonding in Mothers and Their Premature Newborn
Official Title
Efficacy of a Nursing Intervention in the Mother-premature Infant Affective Bond
Study Type
Interventional
2. Study Status
Record Verification Date
February 2020
Overall Recruitment Status
Unknown status
Study Start Date
May 1, 2017 (Actual)
Primary Completion Date
December 30, 2020 (Anticipated)
Study Completion Date
December 30, 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universidad Industrial de Santander
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
This experimental study will determine the effectiveness of nursing intervention "the attachment promotion" to increase the affective bonds between mothers and their premature infants. The assignment of the mothers to the control group will receive usual care, the mothers will be assigned to intervention group will receive the intervention.
Detailed Description
The premature newborn has a high need for positive interactions, which is a challenge for him, due to biological immaturity, and for his mother because of the level of stress that this situation generates. Behavioral and developmental interventions are needed to address the unique behaviors of preterm infants and the interactive capacities of the mother-newborn premature dyad. The project will be conducted in 18 months. The assignment of the mothers to each group will be like that: First at all, mother will be assignment to control group. They will received usual care when achieve the total of 74 mothers, the mothers will be assigned to intervention group.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Premature Infant
Keywords
Premature Infant, Mother-Infant Interaction, Acoustic stimulation/methods, Touch, Visual Stimulation, Vestibule, Labyrinth/physiology
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Sequential Assignment
Model Description
The assignment of the mothers to each group will be like that: First at all, mother will be assignment to control group. They will received usual care when achieve the total of 74 mothers, the mothers will be assigned to intervention group.
Masking
Participant
Allocation
Non-Randomized
Enrollment
148 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Attachment Promotion Intervention
Arm Type
Experimental
Arm Description
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.
Arm Title
Usual Care
Arm Type
No Intervention
Arm Description
Mothers will continue to receive usual which consist in education session about newborn care in home.
Intervention Type
Behavioral
Intervention Name(s)
Attachment Promotion
Intervention Description
Attachment Promotion consists of:
Education session about newborn and mother care.
Training in multisensory stimulation using the ATVV Intervention (auditory, tactile, visual and vestibular)
Two domiciliary visits to follow up and to give education about newborn care and ATVV Intervention.
Daily Phone follows up.
Primary Outcome Measure Information:
Title
Affective bonding score
Description
Changes in the mean score of the nursing outcome: affective bonding measure with the NOC(Nursing Outcomes Classification)
Time Frame
1-6 weeks
Secondary Outcome Measure Information:
Title
Coping adaptation score
Description
Changes in the mean score of the coping measure with the Coping adaptation Processing Scale Abbreviated (CAPS Abbreviated - Spanish)
Time Frame
1-6 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
29 Weeks
Maximum Age & Unit of Time
36 Weeks
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Premature Infant:
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:
Newborn:
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Beatriz Villamizar- carvajal, PhD
Phone
5776345745
Email
beatriz@uis.edu.co
First Name & Middle Initial & Last Name or Official Title & Degree
Mayut Delgado-Galeano, Msc
Phone
573204790489
Email
mayutdelgado@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Beatriz Villamizar- Carvajal, PhD
Organizational Affiliation
Universidad Industrial de Santander
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Carolina Vargas- Porras, Msc
Organizational Affiliation
Universidad Industrial de Santander
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Mayut Delgado-Galeano, Msc
Organizational Affiliation
Universidad Industrial de Santander
Official's Role
Study Chair
Facility Information:
Facility Name
Nursing School, Universidad Industrial de Santander
City
Bucaramanga
State/Province
Santander
ZIP/Postal Code
680002
Country
Colombia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Beatriz Villamizar- Carvajal, PhD
Phone
576345745
Email
beatriz@uis.edu.co
First Name & Middle Initial & Last Name & Degree
Beatriz Villamizar- Carvajal, RN PhD
First Name & Middle Initial & Last Name & Degree
Carolina Vargas- Porras, RN MSc
First Name & Middle Initial & Last Name & Degree
Mayut Delgado- Galeano, RN MSc
Facility Name
Clinica Materno Infantil San Luis
City
Bucaramanga
State/Province
Santander
ZIP/Postal Code
680003
Country
Colombia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
CRISTIAN ORDOÑEZ, Dr.
Phone
5776430026
Ext
495
Email
asistente.medica@clinicasanluis.com.co
Facility Name
Hospital Universitario de Santander
City
Bucaramanga
State/Province
Santander
ZIP/Postal Code
680003
Country
Colombia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Helda Amaya, RN.Director
Phone
577 6450102
Email
heldow2003@yahoo.com
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
22161578
Citation
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.
Results Reference
background
PubMed Identifier
22703676
Citation
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.
Results Reference
background
PubMed Identifier
21045616
Citation
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.
Results Reference
background
PubMed Identifier
21350371
Citation
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.
Results Reference
background
PubMed Identifier
20951514
Citation
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.
Results Reference
background
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Affective Bonding in Mothers and Their Premature Newborn
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