Premature BirthNCT01439269
Family Nurture Intervention (FNI) in Neonatal Intensive Care Unit (NICU)
A study testing Family Nurture Intervention in people with Premature Birth, run by Columbia University at 1 site in United States.
Trial summary
The purpose of this study is to test the efficacy of a family nurture intervention in the neonatal intensive care unit (NICU). Infants receiving enhanced mother-infant and family nurture are compared to infants receiving standard NICU care. Read more about this study
- Who is it for?
- Ages 26 to 34 weeks
- Conditions the study is for
- Premature Birth
- What is being tested?
- Family Nurture Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 394 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2008to 9 Jan 2018
- 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 born a singleton or twin in the Morgan Stanley Children's Hospital in New York City
- Infant is born 26 and 34 weeks post-conceptional age (PCA)
Who cannot join
- Mothers cannot understand or speak English
- Mother has history of drug addiction, psychosis or other severe mental illness
- There is not at least one adult other than the mother in the home
- Infant birth weight is below the third percentile for gestational age
- Infant has significant congenital defects
Trial locations and contacts
1 site in 1 country.
United States1 site
Morgan Stanley Children's Hospital
New York, New York, 10032
About this study
Official title: Enhancement of Co-regulation Between Mother and Infant Via Family Nurture Intervention (FNI) in the NICU: Short and Long Term Effects on Development
The purpose of this study is to test the efficacy of a family nurture intervention in the neonatal intensive care unit (NICU). Infants receiving enhanced mother-infant and family nurture are compared to infants receiving standard NICU care. The intervention enhances mother/infant interactions that are vital to early development in the infant. The main goal is to get the mother and infant into biological synchrony, emotional attunement and mutual calm through an activity referred to as a "calming cycle". Mother's are encouraged to engage in the calming cycle activities as much as possible. Her increased effectiveness in calming her infant is hypothesized to improve the mother's view of her baby, reduce negative emotions about having delivered a baby prematurely, and help her gain confidence in her care-taking abilities, which in other studies predicted shorter length of stay and fewer re-hospitalizations. Another goal is to assist mothers in repeating the calming cycle activities providing appropriate types of stimulation for their babies that are important for social, emotional, and neurobehavioral development. Since preterm babies are often easily upset, mothers will be taught how to comfort and calm their babies. Assessments in the NICU and in follow-up visits for two years will test the immediate and long-term effects of this new approach to the nurture of prematurely born infants.
Read the detailed description
The stress that results from preterm birth, requisite acute care and prolonged physical separation in the NICU can have adverse physiological/psychological effects on both the infant and the mother. In particular, the experience compromises the establishment and maintenance of an optimal mother-infant relationship. Within the neonatal intensive care unit (NICU), parental involvement in care is necessarily superseded by the healthcare staff. Thus, a necessary but detrimental separation between mother and infant is created at a critical period when mother-infant bonding and synchrony should be developing. The physiological challenges associated with being born too soon, along with disturbances in normal mother-infant interactions are key factors underlying the risks of premature infants for a broad range of early and midlife disorders. This study aims to highlight the importance of investigating early interventions that are designed to overcome or reduce the effects of these environmental insults and challenges by implementing a randomized controlled trial of Family Nurture Intervention in the NICU. The most important source of regulatory input is through contact with the mother and her nurturing behavior. Mother-infant interactions are the foundation for the organization of the infant's neurobiological, sensory, perceptual, emotional, physical, and relational systems. The infant's responses to the mother provide critical feedback which shapes her behavior as well. There are many co-regulatory processes embedded in these synchronous and reciprocal interactions which cross neurophysiological and neurobehavioral domains. The intervention is designed to increase biologically important activities and behaviors that enhance maternally-mediated sensory experiences of preterm infants, as well as the infant-mediated sensory experiences in the mother. The investigators hypothesize that repeated engagement of the mother and her infant in the intervention's calming activities will increase the effectiveness of co-regulation and have immediate and long-term beneficial effects for both. The study is assessing the physiological and behavioral outcomes of the infants and mothers receiving Family Nurture Intervention versus Standard Care over the course of the NICU stay.
- Conditions
- Premature Birth
- Being tested
- Family Nurture Intervention
- Keywords
- Separation stress, Family Nurture, Maternal Confidence, Maternal Competence, Calming Cycle, Kangaroo Care, Infant Neurodevelopment, Infant Psychological Development, Post-partum depression, Mother-infant Co-regulation
- Medical subject headings
- Premature Birth, Depression, Postpartum
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Family Nurture InterventionBehavioural
Family Nurture Intervention is facilitated by specially trained Nurture Specialists. The intervention involves calming interactions between mother and infant in the isolette via odor exchange, firm sustained touch and vocal soothing, through calming interactions during holding and feeding via the Calming Cycle and through family sessions designed to engage the help and support of family members for the mother.
| Study group | Role | What they receive |
|---|---|---|
| Phase 1: Standard Care | No intervention | Mothers are given infant care instruction as part of standard care |
| Phase 1: Facilitated infant care | Experimental | Family Nurture Intervention (FNI) Receives: Behavioral: Family Nurture Intervention |
| Phase 2: Effectiveness | Active comparator | All participants receiving FNI Receives: Behavioral: Family Nurture Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Length of Stay
Length of stay will be determined based on the infant's number of days as an inpatient at the Children's Hospital of New York (CHONY) NICU.
Measured: From Infant's birth to discharge from NICU
Secondary outcomes (11)
Safety and Practicability of Intervention
To confirm implementation of the intervention is safe and practicable within the Neonatal Intensive Care Unit (NICU)throughout the study duration.
Measured: up to 5 years
Psychological Assessments: Mothers in both groups are given a wide-range of psychological questionnaires. These include indices of anxiety, depression, temperament, personality, attachment, stress, and social support.
Mothers are administered questionnaires at several time periods to assess levels of anxiety (Speilberger State-Trait Anxiety Inventory), and depressive symptoms (Center for Epidemiological Studies Depression Scale). After group assignment, symptoms of post-partum depression (Postpartum Depression Screening Scale), depressive experiences (Depressive Experiences Questionnaire), qualities of attachments (Adult Attachment Interview) are assessed. Status of inhibitory vs. approach systems (Behavioral Inhibition System-Behavioral Approach System), and Mom's Support Circle are assessed.
Measured: Up to 24 months of Age
Neurobehavioral Assessments of Infants: The use of the NICU Network Neurobehavioral Scale (NNNS) to assess infant's neurodevelopmental status
The test measures neurological reflexes, body tone and motor maturity at 36 weeks (+/- 1 week) and 40 weeks (+/- 1 week) post-conceptional age. It also measures the infant's orientation to and engagement with social and non-social stimuli, the lability of the infant's activity and states, and the infant's consolability. The stress/abstinence scale, originally formulated for prenatally drug-exposed infants, includes physiological, autonomic, skin, central nervous system (CNS), visual and gastrointestinal markers.
Measured: Up to 40 weeks Gestational Age
Neurobehavioral Assessments of Infants: Mothers provide a wide range of information about infant's development through questionnaires
Infant temperament is obtained using the Early Infancy Temperament Questionnaire and the Infant Behavior Questionnaire. Social-emotional problems of the infants are assessed by the Brief Infant-Toddler Social and Emotional Assessment at 4, 12, 18 and 24 months corrected age, and at 12, 18, 24 months CA by the Child Behavior Checklist. The mother also provides information about possible developmental delays by filling out the Ages and Stages Questionnaire, at 4, 12, 18 and 24 months corrected age.
Measured: Up to 24 months corrected age
Neurobehavioral Assessments of Infants- Bayley Scales of Infant and Toddler Development, Bayley III
At 18 and 24 months corrected age, infants are administered the Bayley Scales of Infant and Toddler Development, Bayley III consisting of four subscales: Cognitive, Language (receptive/expressive), Motor (fine/gross) and Social-Emotional. These filmed assessments, made by research staff 'blind' to infant group assignment, provide information about the neurobehavioral status of the child and whether there are significant delays in key domains of motor, language, and cognitive development.
Measured: Up to 24 months corrected age
Physiological Assessments: A one hour recording of high density electroencephalogram (EEG) (128 leads), electrocardiogram (ECG), and respiration during sleep.
EEG and ECG are collected at 1000 samples/sec and respiration at 50 samples/sec at 34, 36, and 39-42 weeks post-conceptional age. Throughout recording, research assistants assign sleep state codes (quiet sleep, active sleep, indeterminate, awake, cry) once each minute, based on behavioral criteria as well as provide estimates of heart rate and heart rate for each sleep state. EEG data is processed to obtain spatially-dependent measures of wave amplitude (power) at specific frequencies for each spatial location and measures of functional connectivity (coherence) between electrode locations.
Measured: Up to 42 weeks post-conceptional age
Physiological Assessments- Cortisol Levels, breast milk, saliva, infant blood samples, and infant stool collection
As a component of the mother-infant interaction assessments conducted at 4 and 12 months corrected age, salivary cortisol levels are measured at four times during each session. These measures provide physiological indices of how the infants respond to a social interaction stressor. In addition, breast milk, saliva (mother and infant), infant stool, and infant blood for peptides are collected.
Measured: Up to 24 months corrected age
Mother-Infant Interactions Assessments: Evaluating the qualities of the mother's interaction with her infant during diaper change
Videos of infant's diaper change are obtained and coded by research team members unfamiliar with the dyads' group assignment at 36 weeks post-conceptional age and 4 months corrected age. The mother is instructed to undress her infant, remove the diaper, wipe clean, and re-dress her infant. These familiar caregiving procedures represent a mild, ecologically valid stressor. Maternal behavior is coded, using a 9-point Likert scale for: (a) Acceptance vs. Rejection; (b) Soothing capability; (c) Consideration vs. Intrusiveness; (d) Quality of Physical Contact; and (e) Quality of Vocal Contact.
Measured: Up to 4 months corrected age
Mother-Infant Interaction Assessments: Mother-infant face-to-face communicative competence, sensitivity of maternal caregiving and mother and infant physiological capacity to cope with a stressor
A split-screen filming session is conducted following protocols and analyzed by team members 'blind' to the dyads' group assignments at 4, 12, and 24 months corrected age. The videotapes consist of: (1) mother-infant play; (2) stranger-infant play (3) diaper change; (4) the Still Face protocol in which mothers assume an expressionless face for two minutes. Primary measures are: infant gaze aversion, mother-infant gaze coordination, infant distress, maternal interaction style (affectionate vs. intrusive), and responses of mothers and infants to gaze aversion.
Measured: Up to 24 months corrected age
Mother-Infant Interaction Assessments- Yale Inventory of Parental Thoughts and Actions (YIPTA)
Twice during each infant's stay in the NICU, and again at term, 4, 12, 18 and 24 months corrected age following discharge, the Yale Inventory of Parental Thoughts and Actions, YIPTA is administered. This inventory quantifies maternal ratings of her thoughts about her infant. To evaluate the mother-to-child attachment processes subscales include: frequency of thoughts/worries about the infant, the distress caused by these thoughts, how she manages her distress, frequency of checking the infant, affiliative interactions, measures of attachment, frequency of care taking behavior.
Measured: up to 24 months corrected age
Assessments of Neonatal Intensive Care Unit Activities: Ascertainment of attendance and the frequency and/or time spent engaged in key aspects of the Family Nurture Intervention using maternal self-report forms.
These forms are filled out after each visit to NICU. The mother is asked to enter information about the start and stop times of each of her visits to the NICU and to estimate the amount of time or number of times she engaged in various types of interactions with her infant. A similar schedule of questionnaires is given to the Standard Care group mothers, but without questions that pertain only to the Family Nurture Intervention group (i.e., odor cloth exchange, Calming Cycle).
Measured: Participants will be followed for the duration of NICU stay, an expected average of 7 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2011 (estimated)
- Study startJun 2008
- Primary completion3 Jul 2012
- Study completion9 Jan 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (15)Papers the sponsor has linked to this study.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 394 participants (actual)
Sponsor and investigators
- Lead sponsor
- Columbia University
- Sponsor type
- University, hospital or other
- Collaborators
- Williams College, New York State Psychiatric Institute
- 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
- NCT01439269
- Sponsor's protocol ID
- AAAD0389
- Status last verified
- Feb 2023
- First submitted
- 19 Sep 2011
- Last updated
- 15 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Ravn IH, Smith L, Lindemann R, Smeby NA, Kyno NM, Bunch EH, Sandvik L. Effect of early intervention on social interaction between mothers and preterm infants at 12 months of age: a randomized controlled trial. Infant Behav Dev. 2011 Apr;34(2):215-25. doi: 10.1016/j.infbeh.2010.11.004. Epub 2011 Mar 2.
PubMed 21371754Muller-Nix C, Forcada-Guex M, Pierrehumbert B, Jaunin L, Borghini A, Ansermet F. Prematurity, maternal stress and mother-child interactions. Early Hum Dev. 2004 Sep;79(2):145-58. doi: 10.1016/j.earlhumdev.2004.05.002.
PubMed 15324994Meijssen D, Wolf MJ, van Bakel H, Koldewijn K, Kok J, van Baar A. Maternal attachment representations after very preterm birth and the effect of early intervention. Infant Behav Dev. 2011 Feb;34(1):72-80. doi: 10.1016/j.infbeh.2010.09.009. Epub 2010 Nov 9.
PubMed 21067812Meijssen D, Wolf MJ, Koldewijn K, Houtzager BA, van Wassenaer A, Tronick E, Kok J, van Baar A. The effect of the Infant Behavioral Assessment and Intervention Program on mother-infant interaction after very preterm birth. J Child Psychol Psychiatry. 2010 Nov;51(11):1287-95. doi: 10.1111/j.1469-7610.2010.02237.x.
PubMed 20345840Shah PE, Clements M, Poehlmann J. Maternal resolution of grief after preterm birth: implications for infant attachment security. Pediatrics. 2011 Feb;127(2):284-92. doi: 10.1542/peds.2010-1080. Epub 2011 Jan 17.
PubMed 21242223Coppola G, Cassibba R, Costantini A. What can make the difference? Premature birth and maternal sensitivity at 3 months of age: the role of attachment organization, traumatic reaction and baby's medical risk. Infant Behav Dev. 2007 Dec;30(4):679-84. doi: 10.1016/j.infbeh.2007.03.004. Epub 2007 Apr 20.
PubMed 17449102DeBoer RW, Karemaker JM, Strackee J. Comparing spectra of a series of point events particularly for heart rate variability data. IEEE Trans Biomed Eng. 1984 Apr;31(4):384-7. doi: 10.1109/TBME.1984.325351. No abstract available.
PubMed 6745974Hofer MA. Early social relationships: a psychobiologist's view. Child Dev. 1987 Jun;58(3):633-47.
PubMed 3608643Als H, Lawhon G, Duffy FH, McAnulty GB, Gibes-Grossman R, Blickman JG. Individualized developmental care for the very low-birth-weight preterm infant. Medical and neurofunctional effects. JAMA. 1994 Sep 21;272(11):853-8.
PubMed 8078162Stevenson NJ, Iyer K, Tokariev A, Roberts JA, Vanhatalo S. Maturation of Neuronal Activity in the Human Cortex Exhibits Robust Spatial Gradients across the Birth Transition. J Neurosci. 2025 Oct 8;45(41):e0610252025. doi: 10.1523/JNEUROSCI.0610-25.2025.
PubMed 40883001Welch MG, Barone JL, Porges SW, Hane AA, Kwon KY, Ludwig RJ, Stark RI, Surman AL, Kolacz J, Myers MM. Family nurture intervention in the NICU increases autonomic regulation in mothers and children at 4-5 years of age: Follow-up results from a randomized controlled trial. PLoS One. 2020 Aug 4;15(8):e0236930. doi: 10.1371/journal.pone.0236930. eCollection 2020.
PubMed 32750063Beebe B, Myers MM, Lee SH, Lange A, Ewing J, Rubinchik N, Andrews H, Austin J, Hane A, Margolis AE, Hofer M, Ludwig RJ, Welch MG. Family nurture intervention for preterm infants facilitates positive mother-infant face-to-face engagement at 4 months. Dev Psychol. 2018 Nov;54(11):2016-2031. doi: 10.1037/dev0000557. Epub 2018 Oct 4.
PubMed 30284883Hane AA, Myers MM, Hofer MA, Ludwig RJ, Halperin MS, Austin J, Glickstein SB, Welch MG. Family nurture intervention improves the quality of maternal caregiving in the neonatal intensive care unit: evidence from a randomized controlled trial. J Dev Behav Pediatr. 2015 Apr;36(3):188-96. doi: 10.1097/DBP.0000000000000148.
PubMed 25757070Welch MG, Hofer MA, Stark RI, Andrews HF, Austin J, Glickstein SB, Ludwig RJ, Myers MM; FNI Trial Group. Randomized controlled trial of Family Nurture Intervention in the NICU: assessments of length of stay, feasibility and safety. BMC Pediatr. 2013 Sep 24;13:148. doi: 10.1186/1471-2431-13-148.
PubMed 24063360Welch MG, Hofer MA, Brunelli SA, Stark RI, Andrews HF, Austin J, Myers MM; Family Nurture Intervention (FNI) Trial Group. Family nurture intervention (FNI): methods and treatment protocol of a randomized controlled trial in the NICU. BMC Pediatr. 2012 Feb 7;12:14. doi: 10.1186/1471-2431-12-14.
PubMed 22314029
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
- Enhancement of Co-regulation Between Mother and Infant Via Family Nurture Intervention (FNI) in the NICU: Short and Long Term Effects on Development
- ClinicalTrials.gov ID
- NCT01439269
- Acronym / sponsor ID
- AAAD0389
- Conditions
- Premature Birth
- Keywords
- Separation stress, Family Nurture, Maternal Confidence, Maternal Competence, Calming Cycle, Kangaroo Care, Infant Neurodevelopment, Infant Psychological Development
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 394 participants (actual)
- Lead sponsor
- Columbia UniversityUniversity, hospital or other
- Collaborators
- Williams College, New York State Psychiatric Institute
- Study start
- Jun 2008 (actual)
- Primary completion
- 3 Jul 2012 (actual)
- Study completion
- 9 Jan 2018 (actual)
- First posted
- 23 Sep 2011 (estimated)
- 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 test the efficacy of a family nurture intervention in the neonatal intensive care unit (NICU). Infants receiving enhanced mother-infant and family nurture are compared to infants receiving standard NICU care. The intervention enhances mother/infant interactions that are vital to early development in the infant. The main goal is to get the mother and infant into biological synchrony, emotional attunement and mutual calm through an activity referred to as a "calming cycle". Mother's are encouraged to engage in the calming cycle activities as much as possible. Her increased effectiveness in calming her infant is hypothesized to improve the mother's view of her baby, reduce negative emotions about having delivered a baby prematurely, and help her gain confidence in her care-taking abilities, which in other studies predicted shorter length of stay and fewer re-hospitalizations. Another goal is to assist mothers in repeating the calming cycle activities providing appropriate types of stimulation for their babies that are important for social, emotional, and neurobehavioral development. Since preterm babies are often easily upset, mothers will be taught how to comfort and calm their babies. Assessments in the NICU and in follow-up visits for two years will test the immediate and long-term effects of this new approach to the nurture of prematurely born infants.
Detailed description
The stress that results from preterm birth, requisite acute care and prolonged physical separation in the NICU can have adverse physiological/psychological effects on both the infant and the mother. In particular, the experience compromises the establishment and maintenance of an optimal mother-infant relationship. Within the neonatal intensive care unit (NICU), parental involvement in care is necessarily superseded by the healthcare staff. Thus, a necessary but detrimental separation between mother and infant is created at a critical period when mother-infant bonding and synchrony should be developing. The physiological challenges associated with being born too soon, along with disturbances in normal mother-infant interactions are key factors underlying the risks of premature infants for a broad range of early and midlife disorders. This study aims to highlight the importance of investigating early interventions that are designed to overcome or reduce the effects of these environmental insults and challenges by implementing a randomized controlled trial of Family Nurture Intervention in the NICU. The most important source of regulatory input is through contact with the mother and her nurturing behavior. Mother-infant interactions are the foundation for the organization of the infant's neurobiological, sensory, perceptual, emotional, physical, and relational systems. The infant's responses to the mother provide critical feedback which shapes her behavior as well. There are many co-regulatory processes embedded in these synchronous and reciprocal interactions which cross neurophysiological and neurobehavioral domains. The intervention is designed to increase biologically important activities and behaviors that enhance maternally-mediated sensory experiences of preterm infants, as well as the infant-mediated sensory experiences in the mother. The investigators hypothesize that repeated engagement of the mother and her infant in the intervention's calming activities will increase the effectiveness of co-regulation and have immediate and long-term beneficial effects for both. The study is assessing the physiological and behavioral outcomes of the infants and mothers receiving Family Nurture Intervention versus Standard Care over the course of the NICU stay.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Phase 1: Standard Care | No intervention | –Mothers are given infant care instruction as part of standard care |
| Phase 1: Facilitated infant care | Experimental | Behavioral: Family Nurture InterventionFamily Nurture Intervention (FNI) |
| Phase 2: Effectiveness | Active comparator | Behavioral: Family Nurture InterventionAll participants receiving FNI |
Who may qualify
- Ages
- 26 to 34 weeks
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Infant is born a singleton or twin in the Morgan Stanley Children's Hospital in New York City
- Infant is born 26 and 34 weeks post-conceptional age (PCA)
Key exclusion criteria (5 listed)
- Mothers cannot understand or speak English
- Mother has history of drug addiction, psychosis or other severe mental illness
- There is not at least one adult other than the mother in the home
- Infant birth weight is below the third percentile for gestational age
- Infant has significant congenital defects
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 InterventionFamily Nurture Intervention is facilitated by specially trained Nurture Specialists. The intervention involves calming interactions between mother and infant in the isolette via odor exchange, firm sustained touch and vocal soothing, through calming interactions during holding and feeding via the Calming Cycle and through family sessions designed to engage the help and support of family members for the mother. | Behavioural | Phase 1: Facilitated infant care, Phase 2: Effectiveness |
Primary outcome
Length of Stay
Time frame: From Infant's birth to discharge from NICU
Length of stay will be determined based on the infant's number of days as an inpatient at the Children's Hospital of New York (CHONY) NICU.
11 secondary outcomes
Safety and Practicability of Intervention
Time frame: up to 5 years
Psychological Assessments: Mothers in both groups are given a wide-range of psychological questionnaires. These include indices of anxiety, depression, temperament, personality, attachment, stress, and social support.
Time frame: Up to 24 months of Age
Neurobehavioral Assessments of Infants: The use of the NICU Network Neurobehavioral Scale (NNNS) to assess infant's neurodevelopmental status
Time frame: Up to 40 weeks Gestational Age
Neurobehavioral Assessments of Infants: Mothers provide a wide range of information about infant's development through questionnaires
Time frame: Up to 24 months corrected age
Neurobehavioral Assessments of Infants- Bayley Scales of Infant and Toddler Development, Bayley III
Time frame: Up to 24 months corrected age
Physiological Assessments: A one hour recording of high density electroencephalogram (EEG) (128 leads), electrocardiogram (ECG), and respiration during sleep.
Time frame: Up to 42 weeks post-conceptional age
Physiological Assessments- Cortisol Levels, breast milk, saliva, infant blood samples, and infant stool collection
Time frame: Up to 24 months corrected age
Mother-Infant Interactions Assessments: Evaluating the qualities of the mother's interaction with her infant during diaper change
Time frame: Up to 4 months corrected age
Mother-Infant Interaction Assessments: Mother-infant face-to-face communicative competence, sensitivity of maternal caregiving and mother and infant physiological capacity to cope with a stressor
Time frame: Up to 24 months corrected age
Mother-Infant Interaction Assessments- Yale Inventory of Parental Thoughts and Actions (YIPTA)
Time frame: up to 24 months corrected age
Assessments of Neonatal Intensive Care Unit Activities: Ascertainment of attendance and the frequency and/or time spent engaged in key aspects of the Family Nurture Intervention using maternal self-report forms.
Time frame: Participants will be followed for the duration of NICU stay, an expected average of 7 weeks
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.
- Background: PubMed 21371754Ravn IH, Smith L, Lindemann R, Smeby NA, Kyno NM, Bunch EH, Sandvik L. Effect of early intervention on social interaction between mothers and preterm infants at 12 months of age: a randomized controlled trial. Infant Behav Dev. 2011 Apr;34(2):215-25. doi: 10.1016/j.infbeh.2010.11.004. Epub 2011 Mar 2.
- Background: PubMed 15324994Muller-Nix C, Forcada-Guex M, Pierrehumbert B, Jaunin L, Borghini A, Ansermet F. Prematurity, maternal stress and mother-child interactions. Early Hum Dev. 2004 Sep;79(2):145-58. doi: 10.1016/j.earlhumdev.2004.05.002.
- Background: PubMed 21067812Meijssen D, Wolf MJ, van Bakel H, Koldewijn K, Kok J, van Baar A. Maternal attachment representations after very preterm birth and the effect of early intervention. Infant Behav Dev. 2011 Feb;34(1):72-80. doi: 10.1016/j.infbeh.2010.09.009. Epub 2010 Nov 9.
- Background: PubMed 20345840Meijssen D, Wolf MJ, Koldewijn K, Houtzager BA, van Wassenaer A, Tronick E, Kok J, van Baar A. The effect of the Infant Behavioral Assessment and Intervention Program on mother-infant interaction after very preterm birth. J Child Psychol Psychiatry. 2010 Nov;51(11):1287-95. doi: 10.1111/j.1469-7610.2010.02237.x.
- Background: PubMed 21242223Shah PE, Clements M, Poehlmann J. Maternal resolution of grief after preterm birth: implications for infant attachment security. Pediatrics. 2011 Feb;127(2):284-92. doi: 10.1542/peds.2010-1080. Epub 2011 Jan 17.
- Background: PubMed 17449102Coppola G, Cassibba R, Costantini A. What can make the difference? Premature birth and maternal sensitivity at 3 months of age: the role of attachment organization, traumatic reaction and baby's medical risk. Infant Behav Dev. 2007 Dec;30(4):679-84. doi: 10.1016/j.infbeh.2007.03.004. Epub 2007 Apr 20.
- Background: PubMed 6745974DeBoer RW, Karemaker JM, Strackee J. Comparing spectra of a series of point events particularly for heart rate variability data. IEEE Trans Biomed Eng. 1984 Apr;31(4):384-7. doi: 10.1109/TBME.1984.325351. No abstract available.
- Background: PubMed 3608643Hofer MA. Early social relationships: a psychobiologist's view. Child Dev. 1987 Jun;58(3):633-47.
- Background: PubMed 8078162Als H, Lawhon G, Duffy FH, McAnulty GB, Gibes-Grossman R, Blickman JG. Individualized developmental care for the very low-birth-weight preterm infant. Medical and neurofunctional effects. JAMA. 1994 Sep 21;272(11):853-8.
- Derived from this study: PubMed 40883001Stevenson NJ, Iyer K, Tokariev A, Roberts JA, Vanhatalo S. Maturation of Neuronal Activity in the Human Cortex Exhibits Robust Spatial Gradients across the Birth Transition. J Neurosci. 2025 Oct 8;45(41):e0610252025. doi: 10.1523/JNEUROSCI.0610-25.2025.
- Derived from this study: PubMed 32750063Welch MG, Barone JL, Porges SW, Hane AA, Kwon KY, Ludwig RJ, Stark RI, Surman AL, Kolacz J, Myers MM. Family nurture intervention in the NICU increases autonomic regulation in mothers and children at 4-5 years of age: Follow-up results from a randomized controlled trial. PLoS One. 2020 Aug 4;15(8):e0236930. doi: 10.1371/journal.pone.0236930. eCollection 2020.
- Derived from this study: PubMed 30284883Beebe B, Myers MM, Lee SH, Lange A, Ewing J, Rubinchik N, Andrews H, Austin J, Hane A, Margolis AE, Hofer M, Ludwig RJ, Welch MG. Family nurture intervention for preterm infants facilitates positive mother-infant face-to-face engagement at 4 months. Dev Psychol. 2018 Nov;54(11):2016-2031. doi: 10.1037/dev0000557. Epub 2018 Oct 4.
- 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
1 site 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 in people with Premature Birth, run by Columbia University 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 2 inclusion and 5 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 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?
Length of Stay (time frame: From Infant's birth to discharge from NICU). 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 NCT01439269, which also lists 15 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 15 Feb 2023.