Premature BirthNCT03267043
Family Nurture Intervention in the NICU at The Valley Hospital
A study testing Family Nurture Intervention (FNI) in people with Premature Birth and Obstetric Labor, Premature, run by Columbia University at 2 sites in United States.
Trial summary
The purpose of this study is to compare neurodevelopment and activity in infants born preterm (25 to 34 1/7 weeks gestational age (GA)) receiving Standard Care (SC) or Family Nurture Intervention (FNI) in the neonatal intensive care unit (NICU). Read more about this study
- Who is it for?
- Ages 26 to 34 weeks
- Conditions the study is for
- Premature Birth, Obstetric Labor, Premature
- What is being tested?
- Family Nurture Intervention (FNI)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 2 sitesUnited States
- Study dates
- 20 Oct 2017to 1 Jul 2020
- 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 26 to 34 weeks
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- infant is between 26 and 33 6/7 weeks gestational age upon admission
- infant is a singleton or twin
Who cannot join
- infant's attending physician does not recommend enrollment in the study
- severe congenital anomalies including chromosomal anomalies
- ultrasound evidence of large parenchymal hemorrhagic infarction (>2 cm, intraventricular hemorrhage grade 3 or 4)
- infant cardiac anomalies
- mother has known history of substance abuse, severe psychiatric illness or psychosis
- status of enrolled subject changes and subject now falls into exclusion criteria
- mother and/or infant has a medical condition that precludes intervention components
- mother and/or infant has a contagion that endangers other participants in the study
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Morgan Stanley Children's Hospital of New York (MSCHONY)
New York, New York, 10032
The Valley Hospital
Ridgewood, New Jersey, 07450
About this study
The purpose of this study is to compare neurodevelopment and activity in infants born preterm (25 to 34 1/7 weeks gestational age (GA)) receiving Standard Care (SC) or Family Nurture Intervention (FNI) in the neonatal intensive care unit (NICU).
The investigators hypothesize that FNI will improve: i) neonatal electroencephalographic activity ii) maternal caregiving and wellbeing (psychological and physiological, and iii) infant behavior and neurodevelopment at 18 months corrected age (CA).
Read more
The two-phase effectiveness study aims to:
- Phase 1 - Examine the existing Standard Care Approximately 35 infants and their mothers
- Phase 2 - Examine effectiveness by implementing FNI unit-wide so that every baby receives the intervention Approximately 35 infants and their mothers
Read the detailed description
This study aims to build upon the findings of the earlier randomized controlled trial (RCT) conducted at the Columbia University Medical Center (CUMC) comparing effects, both physiological and emotional, of the current standard method of encouraging contact between mothers and their babies in the NICU with the more specific approach of Family Nurture Intervention (FNI). In addition to receiving standard care, NICU families assigned to FNI received added intervention that focused on supporting the parents and facilitating emotional connection between mother and infant during the infant's NICU stay.
The investigators wish to conduct an effectiveness trial to evaluate if the family nurture intervention's findings can be replicated on a unit-wide level. This effectiveness trial will take place over two parts. There will be two groups; standard care (SC) and intervention (FNI). Phase 1 of the effectiveness study will evaluate the standard care (SC) group in the unit as a baseline measurement and point of comparison to determine if unit-wide FNI reproduces its prior findings (Phase 2). The standard care group (Phase 1) will receive the current standard of care in the NICU. In Phase 2, FNI will be implemented unit-wide, but infants born between 26 weeks and 0 days to 33 weeks 6 days gestation will be eligible to be enrolled into the study. In addition to receiving standard care, patients enrolled during phase 2 will receive added interventions from the trained FNI nursing staff. These added interventions will include supporting the parents and facilitating contact between mother and infant during their infant's NICU stay.
- Conditions
- Premature Birth, Obstetric Labor, Premature
- Being tested
- Family Nurture Intervention (FNI), Standard Care
- Keywords
- preterm birth, NICU, neonatal, skin to skin, kangaroo care, separation stress, family nurture, maternal confidence, maternal competence, calming cycle, infant neurodevelopment, infant psychological development, mother-infant co-regulation, postpartum depression
- Medical subject headings
- Premature Birth, Obstetric Labor, Premature, Depression, Postpartum
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Family Nurture Intervention (FNI)Behavioural
Also called FNI
Subjects will be guided by the nursing staff through an enhanced program of mother/infant interactions, which include skin-to-skin holding.
Standard CareBehavioural
Also called SC
Established routine care provided on the NICU floor by specially trained health care professionals.
| Study group | Role | What they receive |
|---|---|---|
| Standard Care | Active comparator | Participants enrolled in Phase 1 will be receiving the current standard of care in the NICU at The Valley Hospital. Receives: Behavioral: Standard Care |
| Family Nurture Intervention (FNI) | Experimental | Participants enrolled in Phase 2 will be receiving family nurture intervention (FNI) that focuses on supporting the parents and facilitating emotional connection between mother and infant during the infant's NICU stay. Receives: Behavioral: Family Nurture Intervention (FNI) |
| Standard Care - Case Studies | Active comparator | Participants enrolled as case studies in Phase 1 will be receiving the current standard of care in the NICU at The Valley Hospital. These participants will be those who fall outside the inclusion criteria. Receives: Behavioral: Standard Care |
| FNI - Case Studies | Experimental | Participants enrolled in Phase 2 will be receiving family nurture intervention (FNI) that focuses on supporting the parents and facilitating emotional connection between mother and infant during the infant's NICU stay. These fall outside the inclusion criteria but act as a comparator to the case studies of Phase 1. Receives: Behavioral: Family Nurture Intervention (FNI) |
What is being measured
The primary outcome is the main question the study is designed to answer.
EEG Power in the frontal polar region
Measured in microvolts (µV)^2 for infants.
Measured: Up to 41 weeks gestational age
Secondary outcomes (4)
EEG Coherence in the left frontal polar to right frontal polar region
Coherence is a number between 0-1, generated by looking at the similarity/differences in activity between brain regions through analysis of EEG.
Measured: Up to 41 weeks gestational age
CES-D Score
To examine maternal depression, the Center for Epidemiologic Studies Depression Scale (CES-D) is a 20 item self-report inventory designed to assess current but nonspecific distress rather than clinically diagnosed depression. It is the most frequently used measure in the field of infant research and maternal depression. Items probe for depressive symptoms and attitudes within the past week.
Measured: Up to 18 months
State-Trait Anxiety Inventory (STAI) Score
To examine Maternal Anxiety, the State-Trait Anxiety Inventory (STAI) comprises 2 separate self-report scales of 20 items each that measure state and trait anxiety. The S-Anxiety Scale (measuring state), has been found to be a sensitive indicator of changes in transitory anxiety experienced by patients in counseling, psychotherapy, and behavior-modification programs, and has been used to assess the level of anxiety induced by unavoidable real-life stressors. The T-Anxiety scale has proven useful for identifying persons who differ in motivation or drive level. The STAI has been used in studies examining parents of hospitalized children, the transition to a maternal role, perception of illness severity in infants, and maternal anxiety during pregnancy and fetal attachment.
Measured: Up to 18 months
Neurobehavioral Assessments of Infants - Bayley Scales or Infant and Toddler Development, Bayley III
At the 18 month corrected age follow-up, infants are administered the Bayley Scales of Infant and Toddler Development, Bayley III consisting of three developmental domains: Cognitive, Language (receptive/expressive) and Motor (fine/gross). For each domain, a composite score is provided and is scaled to a mean score of 100 and a standard deviation of 15. A child will receive 1 point for every item successfully completed. The administration of each section will end if the child received 0 points on 5 consecutive items. Scores <70 indicate significant developmental delays and scores <80 indicate mild to moderate developmental delays.
Cognitive Scale - comprised of 91 items Language Scale - comprised of 97 items Motor Scale - comprised of 138 items
Measured: Up to 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Aug 2017
- Study start20 Oct 2017
- Primary completion19 Mar 2020
- Study completion1 Jul 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Premature BirthStudies of the same condition, open and under way.
- More trials run by Columbia UniversityThe sponsor's other registered studies.
- 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
- Other
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- Columbia University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Martha G Welch, Columbia University
- Investigators
- Martha G Welch, MD, Principal investigator, Columbia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03267043
- Sponsor's protocol ID
- AAAR4899
- Status last verified
- Feb 2023
- First submitted
- 28 Aug 2017
- Last updated
- 15 Feb 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 15 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Family Nurture Intervention in the NICU at The Valley Hospital
- ClinicalTrials.gov ID
- NCT03267043
- Acronym / sponsor ID
- AAAR4899
- Conditions
- Premature Birth, Obstetric Labor, Premature
- Keywords
- preterm birth, NICU, neonatal, skin to skin, kangaroo care, separation stress, family nurture, maternal confidence
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Columbia UniversityUniversity, hospital or other
- Study start
- 20 Oct 2017 (actual)
- Primary completion
- 19 Mar 2020 (actual)
- Study completion
- 1 Jul 2020 (actual)
- First posted
- 30 Aug 2017 (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.
The purpose of this study is to compare neurodevelopment and activity in infants born preterm (25 to 34 1/7 weeks gestational age (GA)) receiving Standard Care (SC) or Family Nurture Intervention (FNI) in the neonatal intensive care unit (NICU).
The investigators hypothesize that FNI will improve: i) neonatal electroencephalographic activity ii) maternal caregiving and wellbeing (psychological and physiological, and iii) infant behavior and neurodevelopment at 18 months corrected age (CA).
The two-phase effectiveness study aims to:
- Phase 1 - Examine the existing Standard Care Approximately 35 infants and their mothers
- Phase 2 - Examine effectiveness by implementing FNI unit-wide so that every baby receives the intervention Approximately 35 infants and their mothers
Detailed description
This study aims to build upon the findings of the earlier randomized controlled trial (RCT) conducted at the Columbia University Medical Center (CUMC) comparing effects, both physiological and emotional, of the current standard method of encouraging contact between mothers and their babies in the NICU with the more specific approach of Family Nurture Intervention (FNI). In addition to receiving standard care, NICU families assigned to FNI received added intervention that focused on supporting the parents and facilitating emotional connection between mother and infant during the infant's NICU stay.
The investigators wish to conduct an effectiveness trial to evaluate if the family nurture intervention's findings can be replicated on a unit-wide level. This effectiveness trial will take place over two parts. There will be two groups; standard care (SC) and intervention (FNI). Phase 1 of the effectiveness study will evaluate the standard care (SC) group in the unit as a baseline measurement and point of comparison to determine if unit-wide FNI reproduces its prior findings (Phase 2). The standard care group (Phase 1) will receive the current standard of care in the NICU. In Phase 2, FNI will be implemented unit-wide, but infants born between 26 weeks and 0 days to 33 weeks 6 days gestation will be eligible to be enrolled into the study. In addition to receiving standard care, patients enrolled during phase 2 will receive added interventions from the trained FNI nursing staff. These added interventions will include supporting the parents and facilitating contact between mother and infant during their infant's NICU stay.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Standard Care | Active comparator | Behavioral: Standard CareParticipants enrolled in Phase 1 will be receiving the current standard of care in the NICU at The Valley Hospital. |
| Family Nurture Intervention (FNI) | Experimental | Behavioral: Family Nurture Intervention (FNI)Participants enrolled in Phase 2 will be receiving family nurture intervention (FNI) that focuses on supporting the parents and facilitating emotional connection between mother and infant during the infant's NICU stay. |
| Standard Care - Case Studies | Active comparator | Behavioral: Standard CareParticipants enrolled as case studies in Phase 1 will be receiving the current standard of care in the NICU at The Valley Hospital. These participants will be those who fall outside the inclusion criteria. |
| FNI - Case Studies | Experimental | Behavioral: Family Nurture Intervention (FNI)Participants enrolled in Phase 2 will be receiving family nurture intervention (FNI) that focuses on supporting the parents and facilitating emotional connection between mother and infant during the infant's NICU stay. These fall outside the inclusion criteria but act as a comparator to the case studies of Phase 1. |
Who may qualify
- Ages
- 26 to 34 weeks
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- infant is between 26 and 33 6/7 weeks gestational age upon admission
- infant is a singleton or twin
Key exclusion criteria (8 listed)
- infant's attending physician does not recommend enrollment in the study
- severe congenital anomalies including chromosomal anomalies
- ultrasound evidence of large parenchymal hemorrhagic infarction (>2 cm, intraventricular hemorrhage grade 3 or 4)
- infant cardiac anomalies
- mother has known history of substance abuse, severe psychiatric illness or psychosis
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 |
|---|---|---|
| Family Nurture Intervention (FNI)Also: FNISubjects will be guided by the nursing staff through an enhanced program of mother/infant interactions, which include skin-to-skin holding. | Behavioural | FNI - Case Studies, Family Nurture Intervention (FNI) |
| Standard CareAlso: SCEstablished routine care provided on the NICU floor by specially trained health care professionals. | Behavioural | Standard Care, Standard Care - Case Studies |
Primary outcome
EEG Power in the frontal polar region
Time frame: Up to 41 weeks gestational age
Measured in microvolts (µV)^2 for infants.
4 secondary outcomes
EEG Coherence in the left frontal polar to right frontal polar region
Time frame: Up to 41 weeks gestational age
CES-D Score
Time frame: Up to 18 months
State-Trait Anxiety Inventory (STAI) Score
Time frame: Up to 18 months
Neurobehavioral Assessments of Infants - Bayley Scales or Infant and Toddler Development, Bayley III
Time frame: Up to 18 months
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 15 Feb 2023.
- Individual participant dataSharing planned: Undecided
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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.
Martha G Welch, MD principal investigator
Columbia University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Family Nurture Intervention (FNI) in people with Premature Birth and Obstetric Labor, Premature, run by Columbia University at 2 sites 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 2 inclusion and 8 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 15 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
EEG Power in the frontal polar region (time frame: Up to 41 weeks gestational age). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 15 Feb 2023.