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NL: Huid-op-huid contact tussen moeders en hun voldragen baby’s EN: Skin-to-skin contact in mothers and their full-term infants


- candidate number24110
- NTR NumberNTR5697
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR13-mrt-2016
- Secondary IDsECSW2015-2311-358 Ethics Committee Social Sciences; Radboud University
- Public TitleNL: Huid-op-huid contact tussen moeders en hun voldragen baby’s EN: Skin-to-skin contact in mothers and their full-term infants
- Scientific TitleNL: Huid-op-huid contact om uitkomsten in moeders en hun voldragen baby’s te bevorderen: Een gerandomiseerd onderzoek met controlegroep EN: Skin-to-skin contact to improve outcomes in mothers and their full-term infants: A randomized controlled trial
- ACRONYM/
- hypothesisCompared to the control group, mother-infant dyads who practice at least one daily and continuous hour of skin-to-skin contact for the first five weeks after birth will show: Improved maternal outcomes 1. Mental health: 1.1 lower levels of depressive symptoms (primary outcome); 1.2 lower levels of anxiety; 1.3 lower levels of stress; 1.4 lower levels of traumatic stress related to the delivery; 1.5 better sleep quality. 2. Physical health: 2.1 better physical recovery from to the delivery; 2.2 better health (less illnesses and health problems); 2.3 more frequent and a longer duration of breastfeeding; 2.4 lower levels of physiological stress. 3. Mother-infant relationship: 3.1 better bonding to the infant; 3.2 better quality of maternal caregiving behavior. Improved infant outcomes 1. Behavior: 1.1 lower amounts of daily fussing and crying; 1.2 better sleep quality. 2. Physical health: 2.1 better growth and health (less illnesses and health problems); 2.2 lower levels of physiological stress. 3. General development: 3.1 better regulation capacities; 3.1 better social-emotional capacities; 3.3 better language, cognitive, and motor capacities. Potential underlying mechanisms: 1.1 higher levels of maternal oxytocin concentrations. Maternal oxytocin concentrations will mediate the relationship between skin-to-skin contact and maternal outcomes. 1.2 better infant intestinal microbiota (i.e. faster developing, more diverse, and stable microbiota, fewer potentially pathogenic bacteria). Infant intestinal microbiota will mediate the relationship between skin-to-skin contact and infant outcomes.
- Healt Condition(s) or Problem(s) studiedMaternal care
- Inclusion criteria1. Mothers who just gave birth to their child;
2. Aged ≥ 18;
3. Singleton pregnancy;
4. Infant born at ≥ 37 weeks of pregnancy;
5. Infant birth weight ≥ 2500 gram;
6. Infant ≥7 5-min Apgar score.
- Exclusion criteria1. Drug use during pregnancy;
2. Severe maternal physical or mental health problems;
3. Insufficient understanding of Dutch;
4. Congenital anomalies.
- mec approval receivedno
- multicenter trialno
- randomisedyes
- masking/blindingNone
- controlPlacebo
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-apr-2016
- planned closingdate31-aug-2019
- Target number of participants116
- InterventionsMothers in the skin-to-skin contact condition will be requested and encouraged to provide at least one daily and continuous hour of skin-to-skin contact to their infant for the first 5-weeks after birth. The control group will not be requested and encouraged to provide daily skin-to-skin contact to their infant. Both groups will fill out the same logbooks and questionnaires, will collect the same samples and will perform the same tasks.
- Primary outcomeMaternal outcomes
1. Mental health:
1.1 Depressive symptoms: Edinburgh Postnatal Depression Scale (EPDS) at week 2, week 5, week 12, and year 1
- Secondary outcomeMaternal outcomes
1. Mental health:
1.2 Anxiety: The State-Trait Anxiety Inventory (STAI) at week 2, week 5, week 12, and year 1. 1.3 Stress: The Alledaagse Problemen Lijst (APL) at week 2, week 5, week 12, and year 1. 1.4 Traumatic stress related to the delivery: The Traumatic Event Scale-B (TES-B) at week 2, week 5, week 12, and year 1. 1.5 Sleep quality: An adjusted version of the Karolinska Sleep Diary (KSD) for three consecutive days at week 2, week 5, and week 12. The Pittsburgh Sleep Quality Index (PSQI) at week 12 and year 1.

2. Physical health: 2.1 Physical recovery related to birth: The maternal physical recovery logbook of the maternity carer from the first week after birth will be copied at the home visit in week 5. The Multidimensional Fatigue Inventory (MFI) and the Bodily Pain subscale of the Short Form Health Survey (SF-36) at week 2, week 5, week 12, and year 1.
2.2 Health (illnesses and health problems): The maternal health interview, based on the infant health interview (Beijers, Jansen, Riksen-Walraven, & de Weerth, 2010), during the home visit at week 5. The mother will fill out health questionnaires, based on the infant health interview, at week 12 and year 1 (Beijers et al., 2010).
2.3 Breastfeeding: The mother will note breastfeeding frequency and duration in a weekly logbook for the first twelve weeks after birth. Mothers will note the current feeding status at year 1.
2.4 Physiological stress: A small sample of hair will be collected during the home visit in week 5.

3. Mother-infant relationship:
3.1 Bonding to the infant: The Maternal Postnatal Attachment Scale (MPAS) at week 2, week 5, week 12, and year 1.
3.2.1 Quality of maternal caregiving behavior (sensitivity): Maternal sensitivity will be observed, by the Ainsworth Sensitivity Scales, during a bathing session of the child by the mother at the home visit in week 5.
3.2.2 Quality of maternal caregiving behavior (synchrony): Synchrony will be measured with saliva samples of both the mother and infant before and after the bathing session (undressing, bathing and dressing). Samples will be collected right before undressing (baseline, T1), and 35 (stress, T2) and 40 (recovery, T3) minutes after the infant is taken out of bath. Saliva will be collected in tubes for the mother and with eye-sponges for the child.

Infant outcomes
1. Behavior:
1.1 Crying and fussing: A 72-hours study diary will be filled in by the mother at week 2, week 5, and week 12 (Barr, Kramer, Boisjoly, McVey-White, & Pless, 1988).
1.2 Sleep quality: A 72-hours study diary will be filled out by the mother at week 2, week 5, and week 12 (Barr et al., 1988). The mother will complete an adjusted version of the Brief Infant Sleep Questionnaire (BISQ) at week 2, week 5, week 12 and year 1. On a weekly basis, the mother will fill out self-developed questions related to sleeping arrangement and the number of night wakings between week 1 and week 12.

2. Physical health:
1.1 Growth and health (illnesses and health problems): Growth and weight information will be copied from the well baby clinic logbook at week 12 and year 1. The infant health interview will be performed during the home visit in week 5 (Beijers et al., 2010). Health questionnaires, based on the infant health interview, will be filled out at week 12 and year 1.
1.2 Physiological stress: Saliva will be collected before and two times after the bathing session at the home visit in week 5 (see quality of maternal caregiving behavior (synchrony)).
3. General development:

3.1 Regulation capacities: The Infant Behavior Questionnaire Revised (IBQ-R) at week 12 and year 1 to assess infant regulation capacities with the Orienting/Regulation subscale.
3.2 Language, cognitive, and motor capacities: The Ages and Stages Questionnaire Third Edition (ASQ-3) at year 1. The Personal-Social subscale of the ASQ-3 will be used as a measure for social-emotional capacities (see below).
3.3 Social-emotional capacities: The Brief Infant Toddler Social Emotional Assessment (BITSEA) and the Personal-Social subscale of the ASQ-3.

Potential underlying mechanisms

1.1 Maternal oxytocin concentrations: Three saliva samples during the bathing session, at the same time points as cortisol, will measure maternal oxytocin concentrations (see maternal physiological stress).
1.2 Infant intestinal microbiota: Stool will be collected from the diaper by the parents at week 2, week 5, and year 1.

Additional information

1.1 Medical checklist and eligibility questionnaire: During a telephone call in pregnancy eligibility questions will be answered: age, singleton versus twin pregnancy, number of sibling (for the stratified randomization). The medical checklist will be filled out during the pregnancy home visit to examine severe physical and mental health problems.
1.2 Demographics: Questions related to SES, drugs use, alcohol use, smoking will be filled out in pregnancy.
1.3 Maternal prenatal depression, anxiety, and stress: The EPDS in pregnancy to examine depressive symptoms. The Pregnancy-Related Anxieties Questionnaire-Revised (PRAQ-R) and the STAI to examine anxiety in pregnancy. The Pregnancy Experience Scale (PES) and the APL to examine maternal stress in pregnancy.
1.4 Bonding to the infant prenatally: The Maternal Antenatal Attachment Scale (MAAS) in pregnancy.
1.5 Parental etnographies: The parental etnographies questionnaire in pregnancy and at week 5 (Keller et al., 2003).
1.6 Delivery questionnaire (eligibility and confounders): At week 2, the mother will fill out questions related to the birth of the child (weight, Apgar), the delivery (birth complications), infant sex, and the number of days the father stayed at home after birth.
1.7 Physical contact: With a daily logbook, mothers will fill in with lines the frequency and duration of the time spend in skin-to-skin contact and holding the infant for the first five weeks after birth. Between week 5 and week 12, mothers will note the time spend in skin-to-skin contact on a weekly basis. At year 1, the mother will indicate how many weeks, after the week 12 assessment, they provided skin-to-skin contact to their infant.
1.8 Social support: An adjusted version of the Social Support Effectiveness Interview (SSE-I) questionnaire to examine instrumental, informative, and emotional partner support and negative affect will be filled out in pregnancy and at week 5.
- TimepointsPrenatal phase:

T0: one day between week 34 and week 36 in pregnancy

Postnatal phase:

T1: 2 weeks after birth
T2: 5 weeks after birth
T3: 12 weeks after birth
T4: 1 year after birth

Skin-to-skin contact will be noted every day between the day of birth and week 5, and will be noted on a weekly basis from week 5 until week 12. Breastfeeding and sleep will be noted every week between the day of birth and week 12.
- Trial web sitewww.skippyonderzoek.org
- statusplanned
- CONTACT FOR PUBLIC QUERIESMSc. Kelly Cooijmans
- CONTACT for SCIENTIFIC QUERIESMSc. Kelly Cooijmans
- Sponsor/Initiator Radboud University Nijmegen, Behavioural Science Institute, Radboud University Nijmegen
- Funding
(Source(s) of Monetary or Material Support)
Radboud University Nijmegen, Radboud Universiteit Nijmegen, Behavioural Science Institute
- PublicationsPlanned
- Brief summaryTwenty-to-forty percent of women experience postpartum depressive symptoms, which can affect both the mother and infant. In preterm infants, daily skin-to-skin contact (SSC) between the mother and her infant has been shown to decrease maternal postpartum depressive symptoms. In full-term infants, only two studies investigated SSC effects on maternal depressive symptoms and found similar results. Furthermore, the studies in preterm infants also showed that SSC improves other mental and physical health outcomes of the mother as well as the infant, and improves the quality of mother-infant interactions. One may hypothesize that also in full-term infants, SSC may have additional positive effects for both the mother and infant. This randomized controlled trial will be the first to investigate the effects of a SSC intervention on postpartum maternal depressive symptoms and additional outcomes in mothers and their full-term infants. Additionally, two potential underlying mechanisms will be examined, namely maternal oxytocin concentrations and infant intestinal microbiota. This study provides important information for the development of a feasible, accessible, simple, and cost-effective prevention and (complementary) intervention method that may benefit both the mother and the full-term infant in the short-term and long-term.
- Main changes (audit trail)
- RECORD13-mrt-2016 - 16-apr-2016


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