Affective Bonding in Mothers and Their Premature Newborn

Study Description

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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 Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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
Estimated Study Start Date :	March 2017
Estimated Primary Completion Date :	March 2018
Estimated Study Completion Date :	May 2018

Arms and Interventions

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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: 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.
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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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Contacts

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

Locations

Colombia
Nursing School, Universidad Industrial de Santander	Not yet 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

Sponsors and Collaborators

Universidad Industrial de Santander

Investigators

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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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Publications:

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. Review.

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.

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
Last Update Posted:	March 3, 2017
Last Verified:	February 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD:	No

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:

Premature Birth; Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications