Affective Bonding in Mothers and Their Premature Newborn

Premature Infant Clinical Trial

Official title:

Efficacy of a Nursing Intervention in the Mother-premature Infant Affective Bond

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03070158
• Other study ID #: 1900
• Status: Recruiting
• Phase: N/A
• Start date: May 1, 2017
• Est. completion date: December 30, 2020

Study information

• Verified date: February 2020
• Source: Universidad Industrial de Santander
• Contact: Beatriz Villamizar- carvajal, PhD
• Phone: 5776345745
• Email: beatriz[@]uis.edu.co
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 148
• Est. completion date: December 30, 2020
• Est. primary completion date: December 30, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 29 Weeks to 36 Weeks

Eligibility

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.

Related Conditions & MeSH terms

• Premature Birth
• Premature Infant

Intervention

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.

Locations

Country	Name	City	State
Colombia	Clinica Materno Infantil San Luis	Bucaramanga	Santander
Colombia	Hospital Universitario de Santander	Bucaramanga	Santander
Colombia	Nursing School, Universidad Industrial de Santander	Bucaramanga	Santander

Sponsors (1)

Lead Sponsor	Collaborator
Universidad Industrial de Santander

Country where clinical trial is conducted

Colombia, 

References & Publications (5)

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. — View 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. — View 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. — View 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. Review. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Affective bonding score	Changes in the mean score of the nursing outcome: affective bonding measure with the NOC(Nursing Outcomes Classification)	1-6 weeks
Secondary	Coping adaptation score	Changes in the mean score of the coping measure with the Coping adaptation Processing Scale Abbreviated (CAPS Abbreviated - Spanish)	1-6 weeks