Clinical trial NCT03070158: 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
Overall status: UNKNOWN
Phase: NA
Conditions: Premature Infant
Keywords: Premature Infant
Mother-Infant Interaction
Acoustic stimulation/methods
Touch
Visual Stimulation
Vestibule, Labyrinth/physiology
Lead sponsor: Universidad Industrial de Santander
Sponsor class: OTHER
First posted: 2017-03-03
Enrollment: 148
Sex: ALL
Minimum age (years): 29
Maximum age (years): 36
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
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.
Primary purpose: SUPPORTIVE_CARE

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.

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.

Primary outcomes:
measure: Affective bonding score
timeFrame: 1-6 weeks
Secondary outcomes:
measure: Coping adaptation score
timeFrame: 1-6 weeks
Other outcomes:
Locations:
city: Bucaramanga
country: Colombia
facility: Nursing School, Universidad Industrial de Santander
state: Santander
city: Bucaramanga
country: Colombia
facility: Clinica Materno Infantil San Luis
state: Santander
city: Bucaramanga
country: Colombia
facility: Hospital Universitario de Santander
state: Santander
Study officials:
affiliation: Universidad Industrial de Santander
name: Beatriz Villamizar- Carvajal, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Universidad Industrial de Santander
name: Carolina Vargas- Porras, Msc
role: STUDY_CHAIR
affiliation: Universidad Industrial de Santander
name: Mayut Delgado-Galeano, Msc
role: STUDY_CHAIR
References:
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.
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.
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.
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.
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.