Hypoxic-Ischemic EncephalopathyNCT03837717
The Impact of Holding on Stress and Bonding in Mother-Infant Pairs During Therapeutic Hypothermia
A study testing Holding, Saliva collection and No Holding in people with Hypoxic-Ischemic Encephalopathy and Neonatal Encephalopathy, run by MaineHealth at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 24 hours to 2 days
- Conditions the study is for
- Hypoxic-Ischemic Encephalopathy, Neonatal Encephalopathy
- What is being tested?
- Holding, Saliva collection and No Holding
- Type of treatment
- Injection or infusion, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 1 siteUnited States
- Study dates
- 4 Dec 2018to 8 Feb 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 24 hours to 2 days
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- gestational age at birth of 35 weeks or greater
- absence of clinical or electrographic seizures during the first 24 hours of therapeutic hypothermia
- designation as "clinically stable" by the attending neonatologist on service
- respiratory status of: room air, nasal cannula, continuous positive airway pressure or intubated on conventional ventilator
Who cannot join
- designation as "clinically unstable" by the a member of the medical team
- use of inhaled nitric oxide for persistent pulmonary hypertension of the newborn
- high frequency oscillator ventilation
- presence of electrographic seizures
- use of vasopressors or paralytic agents, presence of chest tubes, wound vacuums, or drains
- in utero opiate exposure
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Impact of Holding During Therapeutic Hypothermia on Saliva Oxytocin and Cortisol Levels in Mother-Infant Pairs
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.
Read the detailed 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.
- Being tested
- Holding, Saliva collection, No Holding
- Keywords
- Saliva, Neonatal Encephalopathy, Hypoxic-Ischemic Encephalopathy, Bonding, Oxytocin, Stress, Cortisol
- Medical subject headings
- Hypoxia-Ischemia, Brain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HoldingBehavioural
Mothers will be assisted with holding their infants (and the cooling blanket) for a single 30-minute period, with the use of a thin foam barrier for thermal protection. Mothers and infants will not be skin-to-skin.
Saliva collectionOther
Saliva will be collected from infants (via syringe suction) and mothers (via passive drool), and tested for levels of cortisol and oxytocin
No HoldingBehavioural
Saliva will be collected from Mothers and infants, and vital sign information will be collected from infants in the same manner as the Holding intervention, with the exception of having mother's hold their infants.
| Study group | Role | What they receive |
|---|---|---|
| Holding First | Experimental | Holding will occur on the second day of hypothermia treatment. Saliva will be collected on Day 2 and Day 3 Receives: Behavioral: Holding; Other: Saliva collection; Behavioral: No Holding |
| No Holding First | Experimental | Holding will occur on the third day of hypothermia treatment. Saliva will be collected on Day 2 and Day 3 Receives: Behavioral: Holding; Other: Saliva collection; Behavioral: No Holding |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in the level of oxytocin in maternal saliva
To compare the change in the level of oxytocin in maternal saliva between two conditions; one assessing the difference between oxytocin levels before and immediately after a 30-minute period of holding during therapeutic hypothermia compared to the second condition in which pre and post-levels of salivary oxytocin surrounding a 30-minute period of "not holding" are obtained.
Measured: 30-minutes
Secondary outcomes (8)
Change in the level of cortisol in maternal saliva
To compare the change in the level of cortisol in maternal saliva between two conditions; one assessing the difference between cortisol levels before and immediately after a 30-minute period of holding during therapeutic hypothermia compared to the second condition in which pre and post-levels of salivary cortisol surrounding a 30-minute period of "not holding" are obtained.
Measured: 30-minutes
Change in the level of oxytocin and cortisol in infant saliva
To compare the change in the level of oxytocin and cortisol in infant saliva between the same two conditions
Measured: 30-minutes
Comparison of infant temperature before, during and after holding
Comparison between the holding and "not holding" conditions of infant temperature in °C, collected 30 minutes prior to holding, every 2 minutes during, and 45 minutes after holding.
Measured: 30 minutes prior to holding, 30 minutes during holding, and 45 minutes after holding.
Comparison of infant heart rate before, during and after holding
Comparison between the holding and "not holding" conditions of infant heart rate in beats per minute, collected 30 minutes prior to holding, every 2 minutes during, and 45 minutes after holding.
Measured: 30 minutes prior to holding, 30 minutes during holding, and 45 minutes after holding.
Comparison of infant blood pressure before, during and after holding
Comparison between the holding and "not holding" conditions of infant mean arterial blood pressure, measured with an arterial line, or, if none present, with systolic and diastolic cuff pressures, collected 30 minutes prior to holding, every 2 minutes during, and 45 minutes after holding.
Measured: 30 minutes prior to holding, 30 minutes during holding, and 45 minutes after holding.
Comparison of infant oxygen saturation before, during and after holding
Comparison between the holding and "not holding" conditions of infant percent oxygen saturation collected 30 minutes prior to holding, every 2 minutes during, and 45 minutes after holding.
Measured: 30 minutes prior to holding, 30 minutes during holding, and 45 minutes after holding.
Subjective maternal reports
Subjective maternal reports of the experience of holding the infant during hypothermia and responses to questions about stress level and bonding.
Measured: Immediately after 30-minutes of holding
Subjective nurse reports
Subjective nurse report about the experience of assisting with holding.
Measured: Immediately after 30-minutes of holding
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2019
- Study start4 Dec 2018
- Primary completion8 Feb 2020
- Study completion8 Feb 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Hypoxic-Ischemic EncephalopathyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Infants and mothers will be randomly assigned to the holding condition occurring on the second versus the third day of hypothermia. On the day of holding, four samples of saliva will be obtained; two from the mother (pre and post holding) and two from the infant (pre and post holding). The first sample will be collected prior to holding, and the second sample immediately at the end of holding before the infant is placed back in the bed. On the day without holding, four additional samples of saliva will be obtained; two from the mother (pre and post "not holding") and two from the infant (pre and post "not holding").
- Masking
- None (open label)
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- MaineHealth
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alexa Craig, MaineHealth
- Investigators
- Alexa K Craig, MD, Principal investigator, MaineHealth
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03837717
- Sponsor's protocol ID
- 1183063
- Status last verified
- Oct 2019
- First submitted
- 7 Feb 2019
- Last updated
- 17 Dec 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Vittner D, McGrath J, Robinson J, Lawhon G, Cusson R, Eisenfeld L, Walsh S, Young E, Cong X. Increase in Oxytocin From Skin-to-Skin Contact Enhances Development of Parent-Infant Relationship. Biol Res Nurs. 2018 Jan;20(1):54-62. doi: 10.1177/1099800417735633. Epub 2017 Oct 11.
PubMed 29017336Craig AK, James C, Bainter J, Evans S, Gerwin R. Parental perceptions of neonatal therapeutic hypothermia; emotional and healing experiences. J Matern Fetal Neonatal Med. 2020 Sep;33(17):2889-2896. doi: 10.1080/14767058.2018.1563592. Epub 2019 Jan 8.
PubMed 30585100Craig AK, Gerwin R, Bainter J, Evans S, James C. Exploring parent expectations of neonatal therapeutic hypothermia. J Perinatol. 2018 Jul;38(7):857-864. doi: 10.1038/s41372-018-0117-8. Epub 2018 May 8.
PubMed 29740186Craig AK, Gerwin R, Bainter J, Evans S, James C. Exploring Parent Experience of Communication About Therapeutic Hypothermia in the Neonatal Intensive Care Unit. Adv Neonatal Care. 2018 Apr;18(2):136-143. doi: 10.1097/ANC.0000000000000473.
PubMed 29595551Craig A, Deerwester K, Fox L, Jacobs J, Evans S. Maternal holding during therapeutic hypothermia for infants with neonatal encephalopathy is feasible. Acta Paediatr. 2019 Sep;108(9):1597-1602. doi: 10.1111/apa.14743. Epub 2019 Mar 5.
PubMed 30721531
Study at a glance
From the registry record, last updated by the sponsor on 17 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Holding During Therapeutic Hypothermia on Saliva Oxytocin and Cortisol Levels in Mother-Infant Pairs
- ClinicalTrials.gov ID
- NCT03837717
- Acronym / sponsor ID
- 1183063
- Keywords
- Saliva, Neonatal Encephalopathy, Hypoxic-Ischemic Encephalopathy, Bonding, Oxytocin, Stress, Cortisol
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- MaineHealthUniversity, hospital or other
- Study start
- 4 Dec 2018 (actual)
- Primary completion
- 8 Feb 2020 (actual)
- Study completion
- 8 Feb 2021 (actual)
- First posted
- 12 Feb 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Infants and mothers will be randomly assigned to the holding condition occurring on the second versus the third day of hypothermia. On the day of holding, four samples of saliva will be obtained; two from the mother (pre and post holding) and two from the infant (pre and post holding). The first sample will be collected prior to holding, and the second sample immediately at the end of holding before the infant is placed back in the bed. On the day without holding, four additional samples of saliva will be obtained; two from the mother (pre and post "not holding") and two from the infant (pre and post "not holding").
| Arm | Type | Receives |
|---|---|---|
| Holding First | Experimental | Behavioral: Holding, Other: Saliva collection, Behavioral: No HoldingHolding will occur on the second day of hypothermia treatment. Saliva will be collected on Day 2 and Day 3 |
| No Holding First | Experimental | Behavioral: Holding, Other: Saliva collection, Behavioral: No HoldingHolding will occur on the third day of hypothermia treatment. Saliva will be collected on Day 2 and Day 3 |
Who may qualify
- Ages
- 24 hours to 2 days
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- gestational age at birth of 35 weeks or greater
- absence of clinical or electrographic seizures during the first 24 hours of therapeutic hypothermia
- designation as "clinically stable" by the attending neonatologist on service
- respiratory status of: room air, nasal cannula, continuous positive airway pressure or intubated on conventional ventilator
Key exclusion criteria (6 listed)
- designation as "clinically unstable" by the a member of the medical team
- use of inhaled nitric oxide for persistent pulmonary hypertension of the newborn
- high frequency oscillator ventilation
- presence of electrographic seizures
- use of vasopressors or paralytic agents, presence of chest tubes, wound vacuums, or drains
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HoldingMothers will be assisted with holding their infants (and the cooling blanket) for a single 30-minute period, with the use of a thin foam barrier for thermal protection. Mothers and infants will not be skin-to-skin. | Behavioural | Holding First, No Holding First |
| Saliva collectionSaliva will be collected from infants (via syringe suction) and mothers (via passive drool), and tested for levels of cortisol and oxytocin | Other | Holding First, No Holding First |
| No HoldingSaliva will be collected from Mothers and infants, and vital sign information will be collected from infants in the same manner as the Holding intervention, with the exception of having mother's hold their infants. | Behavioural | Holding First, No Holding First |
Primary outcome
Change in the level of oxytocin in maternal saliva
Time frame: 30-minutes
To compare the change in the level of oxytocin in maternal saliva between two conditions; one assessing the difference between oxytocin levels before and immediately after a 30-minute period of holding during therapeutic hypothermia compared to the second condition in which pre and post-levels of salivary oxytocin surrounding a 30-minute period of "not holding" are obtained.
8 secondary outcomes
Change in the level of cortisol in maternal saliva
Time frame: 30-minutes
Change in the level of oxytocin and cortisol in infant saliva
Time frame: 30-minutes
Comparison of infant temperature before, during and after holding
Time frame: 30 minutes prior to holding, 30 minutes during holding, and 45 minutes after holding.
Comparison of infant heart rate before, during and after holding
Time frame: 30 minutes prior to holding, 30 minutes during holding, and 45 minutes after holding.
Comparison of infant blood pressure before, during and after holding
Time frame: 30 minutes prior to holding, 30 minutes during holding, and 45 minutes after holding.
Comparison of infant oxygen saturation before, during and after holding
Time frame: 30 minutes prior to holding, 30 minutes during holding, and 45 minutes after holding.
Subjective maternal reports
Time frame: Immediately after 30-minutes of holding
Subjective nurse reports
Time frame: Immediately after 30-minutes of holding
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Dec 2021.
- Background: PubMed 29017336Vittner D, McGrath J, Robinson J, Lawhon G, Cusson R, Eisenfeld L, Walsh S, Young E, Cong X. Increase in Oxytocin From Skin-to-Skin Contact Enhances Development of Parent-Infant Relationship. Biol Res Nurs. 2018 Jan;20(1):54-62. doi: 10.1177/1099800417735633. Epub 2017 Oct 11.
- Background: PubMed 30585100Craig AK, James C, Bainter J, Evans S, Gerwin R. Parental perceptions of neonatal therapeutic hypothermia; emotional and healing experiences. J Matern Fetal Neonatal Med. 2020 Sep;33(17):2889-2896. doi: 10.1080/14767058.2018.1563592. Epub 2019 Jan 8.
- Background: PubMed 29740186Craig AK, Gerwin R, Bainter J, Evans S, James C. Exploring parent expectations of neonatal therapeutic hypothermia. J Perinatol. 2018 Jul;38(7):857-864. doi: 10.1038/s41372-018-0117-8. Epub 2018 May 8.
- Background: PubMed 29595551Craig AK, Gerwin R, Bainter J, Evans S, James C. Exploring Parent Experience of Communication About Therapeutic Hypothermia in the Neonatal Intensive Care Unit. Adv Neonatal Care. 2018 Apr;18(2):136-143. doi: 10.1097/ANC.0000000000000473.
- Background: PubMed 30721531Craig A, Deerwester K, Fox L, Jacobs J, Evans S. Maternal holding during therapeutic hypothermia for infants with neonatal encephalopathy is feasible. Acta Paediatr. 2019 Sep;108(9):1597-1602. doi: 10.1111/apa.14743. Epub 2019 Mar 5.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alexa K Craig, MD principal investigator
MaineHealth
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Holding, Saliva collection and No Holding in people with Hypoxic-Ischemic Encephalopathy and Neonatal Encephalopathy, run by MaineHealth at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Dec 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in the level of oxytocin in maternal saliva (time frame: 30-minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03837717, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Dec 2021.