Clinical Trials Logo
  1. Home
  2. Hypoxic-ischemic Encephalopathy
  3. NCT03837717

The Impact of Holding on Stress and Bonding in Mother-Infant Pairs During Therapeutic Hypothermia

Hypoxic-Ischemic Encephalopathy Clinical Trial

Official title:
The Impact of Holding During Therapeutic Hypothermia on Saliva Oxytocin and Cortisol Levels in Mother-Infant Pairs

Clinical Trial Summary

This research is being done to try to improve the experience of mothers and babies during therapeutic hypothermia. Currently, mothers are not able to hold their baby during hypothermia treatment. Mothers have reported that not being able to hold their baby during this time is stressful. Additionally, it is known that holding has many benefits for mothers' and babies' psychological and physical health. Therapeutic hypothermia is the standard of care. The experimental interventions of this study are to have mothers hold their babies during this treatment, collect saliva samples from mothers and babies, and test the saliva samples for the hormones cortisol and oxytocin. The investigators will test saliva of infants and their mothers before and after holding. The investigators hope to demonstrate decreased cortisol, a marker for stress, and increased oxytocin, a marker for bonding, in infants and mothers while they are held during therapeutic hypothermia.

Clinical Trial Description

The inability to hold an infant being treated with therapeutic hypothermia in the neonatal intensive care unit has been subjectively reported by ours and other research groups as a significant source of stress for parents. The investigators aim to assess the impact of holding on endocrinological markers of stress and bonding. Specifically, the investigators plan to collect salivary cortisol and oxytocin levels from infants undergoing therapeutic hypothermia and their mothers prior to and immediately after a 30-minute holding period. The investigators hypothesize that measurable increases in salivary oxytocin levels, coinciding with the reported qualitative increased levels of bonding, will be observed after the holding period. The investigators anticipate the reported stress reduction after holding to be quantified by measurable decreases in salivary cortisol levels. The investigators hypothesize these hormone changes will be present in both the mother and the infant when compared to samples taken without the holding intervention. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT03837717
Study type Interventional
Source MaineHealth
Contact
Status Completed
Phase N/A
Start date December 4, 2018
Completion date February 8, 2021
View Details
See also
  Status Clinical Trial Phase
Active, not recruiting NCT05048550 - Babies in Glasses; a Feasibility Study. N/A
Recruiting NCT05514340 - Assess Safety and Efficacy of Sovateltide in Hypoxic-ischemic Encephalopathy Phase 2
Recruiting NCT05836610 - Hydrocortisone Therapy Optimization During Hypothermia Treatment in Asphyxiated Neonates Phase 4
Completed NCT03024021 - Cerebral Oxymetry and Neurological Outcome in Therapeutic Hypothermia
Completed NCT01913340 - Neonatal Erythropoietin And Therapeutic Hypothermia Outcomes in Newborn Brain Injury (NEATO) Phase 1/Phase 2
Enrolling by invitation NCT02260271 - Florida Neonatal Neurologic Network
Terminated NCT01192776 - Optimizing (Longer, Deeper) Cooling for Neonatal Hypoxic-Ischemic Encephalopathy(HIE) N/A
Completed NCT06344286 - The Effects of Minimal Enteral Nutrition on Mesenteric Blood Flow and Oxygenation in Neonates With HIE N/A
Recruiting NCT05901688 - Umbilical Cord Abnormalities in the Prediction of Adverse Pregnancy Outcomes
Recruiting NCT02894866 - Hyperbaric Oxygen Therapy Improves Outcome of Hypoxic-Ischemic Encephalopathy N/A
Recruiting NCT03657394 - Comparative Outcomes Related to Delivery-room Cord Milking In Low-resourced Kountries N/A
Recruiting NCT03682042 - Comparative Outcomes Related to Delivery-room Cord Milking In Low-resourced Kountries Developmental Follow Up N/A
Withdrawn NCT03681314 - Umbilical Cord Milking in Neonates Who Are Depressed at Birth-Developmental Follow Up (MIDAB-FU) N/A
Completed NCT03485781 - Propofol-induced EEG Changes in Hypoxic Brain Injury
Not yet recruiting NCT06429007 - A Safety and Feasibility Trial Protocol of Metformin in Infants After Perinatal Brain Injury Phase 2
Recruiting NCT05568264 - Effects of a Physical Therapy Intervention on Motor Delay in Infants Admitted to a Neonatal Intensive Care Unit N/A
Not yet recruiting NCT06448780 - Dose Optimization of Caffeine for HIE Phase 1
Completed NCT02264808 - Developmental Outcomes
Completed NCT05687708 - Effect of Non-nutritive Sucking on Transition to Oral Feeding in Infants With Asphyxia N/A
Recruiting NCT06195345 - Individual Cerebral Hemodynamic Oxygenation Relationships (ICHOR 1)