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Status unknownNCT03070158Updated Feb 7, 2020

Affective Bonding in Mothers and Their Premature Newborn

An interventional study of Attachment Promotion in Premature Infant, sponsored by Universidad Industrial de Santander. Status unknown at 3 sites in Colombia. Open to participants aged 29 Weeks to 36 Weeks. Per ClinicalTrials.gov, last updated 2020-02-07.

Sponsored by Universidad Industrial de Santander · Not applicable, Interventional, and Supportive care

The sponsor has not verified this record recently (last verified Feb 2020), so the status shown — last known as Recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
148
Allocation
Non-randomized
Ages
29 Weeks to 36 Weeks
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Premature Infant

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Keywords

  • Premature Infant
  • Mother-Infant Interaction
  • Acoustic stimulation/methods
  • Touch
  • Visual Stimulation
  • Vestibule, Labyrinth/physiology
03

In context

Premature Birth

2,550 studies on the registry are indexed under Premature Birth; 500 are open to participants now.

This study's planned enrollment of 148 is above the median of 84 across 1,666 interventional studies indexed under Premature Birth.

Browse Premature Birth studies →

Lead sponsor

Universidad Industrial de Santander is the lead sponsor of 11 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
29 Weeks to 36 Weeks
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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.
05

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Non-randomized
Intervention model
Sequential assignment
Masking
Single (Participant)
Enrollment
148 participants (estimated)

Study arms

  • 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

  • No intervention
    Usual Care

    Mothers will continue to receive usual which consist in education session about newborn care in home.

Interventions

  • BehavioralAttachment 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.

06

What researchers measure

Primary outcomes

  1. Affective bonding score

    Changes in the mean score of the nursing outcome: affective bonding measure with the NOC(Nursing Outcomes Classification)

    Time frame: 1-6 weeks

Secondary outcomes

  1. Coping adaptation score

    Changes in the mean score of the coping measure with the Coping adaptation Processing Scale Abbreviated (CAPS Abbreviated - Spanish)

    Time frame: 1-6 weeks

07

Study locations

3 of 3 sites recruiting
  • Nursing School, Universidad Industrial de Santander
    Bucaramanga, Santander 680002, Colombia
    Recruiting
    • Beatriz Villamizar- Carvajal, PhD · Contactbeatriz@uis.edu.co · 576345745
    • Beatriz Villamizar- Carvajal, RN PhD · Principal investigator
    • Carolina Vargas- Porras, RN MSc · Sub investigator
    • Mayut Delgado- Galeano, RN MSc · Sub investigator
  • Clinica Materno Infantil San Luis
    Bucaramanga, Santander 680003, Colombia
    Recruiting
  • Hospital Universitario de Santander
    Bucaramanga, Santander 680003, Colombia
    Recruiting
08

References and documents

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. PubMed 22161578 ↗
  • 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. PubMed 22703676 ↗
  • 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. PubMed 21045616 ↗
  • 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. PubMed 21350371 ↗
  • 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. PubMed 20951514 ↗

Individual participant data

Plan to share: No

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started May 2017 (actual). Primary completion is estimated for Dec 2020, 43 months after the start.

Of 741 non-industry interventional studies with no phase under Premature Birth, half reached primary completion within 24 months of starting (the median), counting those still running; a quarter within 12 and three quarters within 47. This study's planned 43 months is above that.

Counting every sponsor, half of 759 studies reached it within 24 months; a quarter within 12 and three quarters within 47.

How these figures are worked out, and which studies are left out of them.

Registered
Feb 28, 2017
First posted
Mar 3, 2017
StartActual
May 1, 2017
Primary completionEst.
Dec 30, 2020
CompletionEst.
Dec 30, 2020
Last update
Feb 7, 2020
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Feb 7, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03070158
Lead sponsor
Universidad Industrial de Santander
Responsible party
Beatriz Villamizar Carvajal (Principal Investigator, Universidad Industrial de Santander) — Principal investigator
First posted
Mar 3, 2017
Start date
May 1, 2017
Primary completion
Dec 30, 2020 (estimated)
Completion
Dec 30, 2020 (estimated)
Last update
Feb 7, 2020

Study contacts

Beatriz Villamizar- carvajal, PhD
Contact
beatriz@uis.edu.co
5776345745
Mayut Delgado-Galeano, Msc
Contact
mayutdelgado@gmail.com
573204790489
Beatriz Villamizar- Carvajal, PhD
principal investigator · Universidad Industrial de Santander
Carolina Vargas- Porras, Msc
study chair · Universidad Industrial de Santander
Mayut Delgado-Galeano, Msc
study chair · Universidad Industrial de Santander

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Feb 2020. You cannot join it, but the record below documents what was studied.

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