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Affective Bonding in Mothers and Their Premature Newborn

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ClinicalTrials.gov Identifier: NCT03070158
Recruitment Status : Recruiting
First Posted : March 3, 2017
Last Update Posted : May 2, 2018
Sponsor:
Information provided by (Responsible Party):
Beatriz Villamizar Carvajal, Universidad Industrial de Santander

Study Description
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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.

Condition or disease Intervention/treatment Phase
Premature Infant Behavioral: Attachment Promotion Not Applicable

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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 148 participants
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Intervention 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: Single (Participant)
Primary Purpose: Supportive Care
Official Title: Efficacy of a Nursing Intervention in the Mother-premature Infant Affective Bond
Actual Study Start Date : May 1, 2017
Estimated Primary Completion Date : November 30, 2018
Estimated Study Completion Date : May 31, 2019
Arms and Interventions
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Arm Intervention/treatment
Experimental: 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.
 Behavioral: 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.
No Intervention: Usual Care
Mothers will continue to receive usual which consist in education session about newborn care in home.


Outcome Measures
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Primary Outcome Measures :
  1. Affective bonding score [ Time Frame: 1-6 weeks ]
    Changes in the mean score of the nursing outcome: affective bonding measure with the NOC(Nursing Outcomes Classification)


Secondary Outcome Measures :
  1. Coping adaptation score [ Time Frame: 1-6 weeks ]
    Changes in the mean score of the coping measure with the Coping adaptation Processing Scale Abbreviated (CAPS Abbreviated - Spanish)


Eligibility Criteria
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Ages Eligible for Study:   29 Weeks to 36 Weeks   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03070158


Contacts
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Contact: Beatriz Villamizar- carvajal, PhD 5776345745 beatriz@uis.edu.co
Contact: Mayut Delgado-Galeano, Msc 573204790489 mayutdelgado@gmail.com

Locations
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Colombia
Nursing School, Universidad Industrial de Santander Recruiting
Bucaramanga, Santander, Colombia, 680002
Contact: Beatriz Villamizar- Carvajal, PhD    576345745    beatriz@uis.edu.co   
Principal Investigator: Beatriz Villamizar- Carvajal, RN PhD         
Sub-Investigator: Carolina Vargas- Porras, RN MSc         
Sub-Investigator: Mayut Delgado- Galeano, RN MSc         
Clinica Materno Infantil San Luis Recruiting
Bucaramanga, Santander, Colombia, 680003
Contact: CRISTIAN ORDOÑEZ, Dr.    5776430026 ext 495    asistente.medica@clinicasanluis.com.co   
Hospital Universitario de Santander Recruiting
Bucaramanga, Santander, Colombia, 680003
Contact: Helda Amaya, RN.Director    577 6450102    heldow2003@yahoo.com   
Sponsors and Collaborators
Universidad Industrial de Santander
Investigators
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Principal Investigator: Beatriz Villamizar- Carvajal, PhD Universidad Industrial de Santander
Study Chair: Carolina Vargas- Porras, Msc Universidad Industrial de Santander
Study Chair: Mayut Delgado-Galeano, Msc Universidad Industrial de Santander
More Information
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Publications:

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Responsible Party: Beatriz Villamizar Carvajal, Principal Investigator, Universidad Industrial de Santander
ClinicalTrials.gov Identifier: NCT03070158     History of Changes
Other Study ID Numbers: 1900
First Posted: March 3, 2017    Key Record Dates
Last Update Posted: May 2, 2018
Last Verified: April 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Beatriz Villamizar Carvajal, Universidad Industrial de Santander:
Premature Infant
Mother-Infant Interaction
Acoustic stimulation/methods
 Touch
Visual Stimulation
Vestibule, Labyrinth/physiology

Additional relevant MeSH terms:
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Premature Birth
Obstetric Labor, Premature
Obstetric Labor Complications
Pregnancy Complications