Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Affective Bonding in Mothers and Their Premature Newborn

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03070158
Recruitment Status : Recruiting
First Posted : March 3, 2017
Last Update Posted : February 7, 2020
Sponsor:
Information provided by (Responsible Party):
Beatriz Villamizar Carvajal, Universidad Industrial de Santander

Tracking Information
First Submitted Date  ICMJE February 28, 2017
First Posted Date  ICMJE March 3, 2017
Last Update Posted Date February 7, 2020
Actual Study Start Date  ICMJE May 1, 2017
Estimated Primary Completion Date December 30, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 28, 2017)
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)
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: February 28, 2017)
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)
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Affective Bonding in Mothers and Their Premature Newborn
Official Title  ICMJE Efficacy of a Nursing Intervention in the Mother-premature Infant Affective Bond
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE 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
Condition  ICMJE Premature Infant
Intervention  ICMJE 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.
Study Arms  ICMJE
  • 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.
    Intervention: Behavioral: Attachment Promotion
  • No Intervention: Usual Care
    Mothers will continue to receive usual which consist in education session about newborn care in home.
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: February 28, 2017)
148
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 30, 2020
Estimated Primary Completion Date December 30, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 29 Weeks to 36 Weeks   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Beatriz Villamizar- carvajal, PhD 5776345745 beatriz@uis.edu.co
Contact: Mayut Delgado-Galeano, Msc 573204790489 mayutdelgado@gmail.com
Listed Location Countries  ICMJE Colombia
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03070158
Other Study ID Numbers  ICMJE 1900
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Beatriz Villamizar Carvajal, Universidad Industrial de Santander
Study Sponsor  ICMJE Universidad Industrial de Santander
Collaborators  ICMJE Not Provided
Investigators  ICMJE
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
PRS Account Universidad Industrial de Santander
Verification Date February 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP